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VALLEYLAB RF CATHETER ELECTRODE RADIOFREQUENCY ELECTRODE

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					VALLEYLAB RF CATHETER ELECTRODE                                            back to search
RADIOFREQUENCY ELECTRODE                                                           results

Catalog Number FKDISCTRODE
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
During the annuloplasty, the temperature inside (that pt's) disc fluctuated between 30 and
40 degrees celsius though the device's thermostat was set to approx. 55 degrees celsius. "
the petition alleges that the tyco defendants knew or should have known that it s
disctrode equipment was incompatible with the equipment of another manufacturer and
also should have warned about the risks of using its equipment during a procedure where
fluctuating temperatures were observed and about performing a nucleoplasty after an
annuloplasty.



VALLEYLAB RFG-3C PLUS SYSTEM, 117V/60HZ                                    back to search
RADIOFREQUENCY GENERATOR                                                           results

Catalog Number RFG3C11760
Event Type Injury Patient Outcome Other;
Event Description
Procedure: annuloplasty. Based on the info reported in the operative notes and medical
records: the pt underwent the procedure without incident, there is no reported event
related to the rfg generator. Approx 1. 5 hours post procedure medical staff attempted to
make the pt ambulatory. The pt denied numbness in their lower extremities, however,
they were unable to walk or had a tough time doing so. At 8 hours post procedure the pt
was still unable to walk, however, they could take small steps with help. At 10 hours
post procedure the pt was transferred to another hosp for overnight for observation.
Current pt status is unknown.




VALLEYLAB RFG-3C PLUS SYSTEM, 117V/60HZ RADIO                              back to search
FREQUENCY GENERATOR                                                                results

Catalog Number RFG3C11760
Event Type Injury Patient Outcome Other;
Event Description
Procedure: right l-5 dorsal nerve ganglion neurolysis. Reportedly, the pt suffered severe
injury and damage to their body when excessive temperature and/or voltage or amperage
were applied with the device.
VALLEYLAB - USS RFG-3C PLUS SYSTEM, 117V/60HZ                                      back to
RADIOFREQUENCY LESIONING GENERATOR                                           search results

Catalog Number C112TC
Event Type Malfunction Patient Outcome Other;
Event Description
Procedure: radiofrequency lesioning. The pt complained of a shock when the dr pressed
the stimulation button. Dr continued on with the same unit. No injury.



RADIONICS RF LESION GENERATOR                                        back to search results

Model Number RFG-3C PLUS
Patient Outcome Required Intervention;
Event Description
While performing radiofrequency thermocoagulation the generator began making an
alarm noise and an electrical smell was observed. The generator was immediately turned
off and the procedure was discontinued. Pt did receive blistering at bovie pad site. Pt has
developed an infection and is undergoing treatment.



                                                                              back to
     RADIONICS RADIONICS RADIOFREQUENCY
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     GENERATOR RADIO FREQUENCY GENERATOR
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     Model Number RFG-3CF(117-60)
     Event Type Malfunction
     Event Description
     The customer indicated that the temperature probe is not registering. The
     patient could feel the heat. No patient injury was reported.

     Manufacturer Narrative
     The returned generator was visually inspected and no manufacturing defects
     were observed that would cause or contribute to the customer's report. The
     temperature was measured from the internal thermocouples tc-1, tc-2 and
     thermistor, and found to be low. The problem was isolated to the temp circuit
     board. The circuit board was replaced and the generator was found to function
     properly and within all specifications. The temp circuit board supplier has
     since been discontinued.
RADIONICS RADIOFREQUENCY PULSE GENERATOR                              back to search results

Model Number RFG-3C+(117-60)
Event Type Injury Patient Outcome Other;
Event Description
The dr was doing a procedure near the clavical medial branch and lesioned the pt's spinal
cord. Radionic's does not know the condition of the pt except there was injury.

Manufacturer Narrative
The returned generator was found to function properly and within all specifications. No
conditions were found with the generator that would have caused or contributed to a pt
injury.



RADIONICS RADIOFREQUENCY GENERATOR                                    back to search results

Model Number RFG-3C PLUS
Event Type No Answer Provided
Event Description
Unit is shorting out and giving the patient a shock. The unit is reset and if shoots up
temperature.



RADIONICS RADIONICS RADIOFREQUENCY                                           back to search
GENERATOR                                                                            results

Model Number RFG-3CF
Event Type No Answer Provided
Event Description
Unit is shorting out and giving the patient a shock. The unit is reset and if shoots up
temperature.

Manufacturer Narrative
Condition as received by quality assurance technician. - visial inspection of the generator
found no manufacturing defects that would cause or contribute to the customer's report. -
the generator was powered up and went through self-test to ready mode normally. -
during the rf variation test, the gneerator failed the temperature variation test (20% high
out of specification), confirming the customer's report of the temperature shooting up. -
the troubleshooting isolated the cause to the tc-2 calbe assembly. - a continuity test found
that the cable had an intermitted internal connection. - the tc-2 cable was replaced. - the
cause of the intermittent connection cannot be determined. - this failure could cause an
unexpected amount of energy to be delivered to the surgical site. The visual inspection
found the unit did not have the latest revision software installed. - the generator was
upgraded with the latest software release for this model. - the revision level of the
software would not cause or contribute to the customer's report. The generator was
inspected for signs of metal to metal arcing that could cause or contribute to patient
shocks, none were found. - the low frequency leakage currents were also tested and were
found to be normal and within specifications. - in addition, the ground continuity was
tested and was found to be normal and with speicifications. - the cause of the patient
shock cannot be determined. - radionics addresses patient stimulus (shock) in the rfg-3c
plus user's manual, (appendix b). - the generator was cycled on the bench in automatic
temperature control model for a period of two hours and no problems were noted. - the
generator was placed on a chart recorder and cycled at max power for a period of four
hours (50% duty cycle) and no problems were noted. - the generator was final tested and
was found to function normally and within specifications. Failed components: tc2 cable,
front panel, p/n: s207500729, markings: none. Query results: a query of the return
authorization system (r. A. S. ) database revealed one other confirmed related report for
the tc-2 cable on the rfg 3c generators in the last twelve months. Service record review: a
review of the service history indicates no prior service histories are recorded for this
generator.


RADIONICS BFG-3C RADIOFREQUENCY GENERATOR                                     back to search
RFG-3C                                                                                results

Model Number RFG-3C
Event Type Other Patient Outcome Other;
Event Description
There were three lesions of coin shaped about an inch in diameter each. According to the
lesions three phlyctenes (burning) were observed to a light 2nd degree burn. The
operated temp was at 80 degrees c during 90 secs. The pt was laying on the stomach,
highly anesthetized but not locally and not completely. Two thermocoagulation were
being performed by the neurosurgeon on lumbar region (l4-l5) and (l5-s1).

Manufacturer Narrative
This report is based on info supplied by others. Neither the submission of this report or
any statement made in it is intended to be an admission that any radionics device is
defective or has malfunctioned; that any a death or serious injury has occurred; or that
any radionics device contributed to or is likely to contribute to a death or serious injury if
a malfunction occurred.

Event Description
Reported event: pt was lying on their stomach with a homemade grounding pad placed
on the abdomen. Two lesion sites were operated on the lumbar regions between
vertebras l4-l5 and l5-s1. Burning appeared on the left abdominal, opposite of the lesion,
near the pad.



     RADIONICS RFG-3C PLUS RADIOFREQUENCY                              back to search
     LESION GENERATOR                                                          results

     Model Number RFG-3C PLUS
     Event Type Injury Patient Outcome Other;
     Event Description
     One hour before surgery, dr checked generator in the or. During the check the
     generator failed to record or sense temperature. After a few trials, the
     generator was able to record temperature. The dr proceeded to do surgery
     using a tm electrode. During lesion mode the generator failed to register
     temperature and output and energy was so great that the brain tissue
     carbonized and stuck to the exposed tip of the electrode. This caused a
     subthalamic hemorrhage and pt went into a deep coma.

     Manufacturer Narrative
     Eval summary: the rfg-3 c plus was returned on 8/3/2000 for an eval on the
     event that occurred on 6/22/2000. The device was an rfg-3c plus generator,
     which is a frequency lesion generator. Investigation: upon receiving the unit
     radionics rf engineer manager simulated the reported temperature error in
     manual mode with no increase in the output power. The unit operated as
     expected. Similar test in automatic temperature controlled lesion mode were
     done. If the temperature sensor connection was opened before the on button is
     pressed the output will not run. When the temperature sensor connection was
     opened, after the on button is pressed, the temperature display goes to dashes,
     as it should. The output power instead of turning off (temperature out of
     range) starts to increase until it reaches maximum. At the beginning of the
     lesion, the user is instructed to turn the output control to maximum. This
     allows the generator to control the output. Manual mode still remains. At all
     times the output control knob can turn the output down to minimum if the
     user notices the temperature is not reading or the power is increasing above
     the values typically seen in the procedure. Since the temperature monitoring
     must be functional to start the lesion, it is unlikely that this temperature
     ramping would happen in actual application. Radionics has been producing
     the rfg-3c plus for more than two years and this is the first reported case of
     this rare combination. If this were to reoccur there are safety features built in
     to minimize danger, specifically, the size of the electrode tip exposure and the
     impedance cutout function of the unit limit the lesion size. Corrective action:
     the code is currently being modified so that if the temperature is ever out of
     range after the on button has been pressed and a valid temperature was
     measured the output is shutoff. The change will be mandatory in all rfg-3c
     plus generators when they are returned for yearly calibration.

     Manufacturer Narrative
     This report is based on info supplied by others. Neither the submission of this
     report or any statement made in it is intended to be an admission that any
     radionics device is defective or has malfunctioned; that a death or serious
     injury has occurred; or that any radionics device contributed to or is likely to
     contribute to a death or serious injury if a malfunction occurred. The rfg-3 c
     plus was returned on 8/3/2000 for an eval on the event that occurred on
     6/22/2000. The device was an rfg-3c plus generator, which is a frequency
     lesion generator s/n 915-274. Investigation upon receiving the unit radionics
     rf engineer manager simulated the reported temperature error in manual mode
     with no increase in the output power. The unit operated as expected. Similar
     test in automatic temperature controlled lesion mode were done. If the
     temperature sensor connection was opened before the on button is pressed the
     output will not run. When the temperature sensor connection was opened,
     after the on button is pressed, the temperature display goes to dashes, as it
     should. The output power instead of turning off (temperature out of range)
     starts to increase until it reaches maximum. At the beginning of the lesion, the
     user is instructed to turn the output control to maximum. This allows the
     generator to control the output. Manual mode still remains. At all times the
     output control knob can turn the output down to minimum if the user notices
     the temperature is not reading or the power is increasing above the values
     typically seen in the procedure. Since the temperature monitoring must be
     functional to start the lesion, it is unlikely that this temperature ramping
     would happen in actual application. Radionics has been producing the rfg-3c
     plus for more than two years and this is the first reported case of this rare
     combination. If this were to reoccur there are safety features built in to
     minimize danger, specifically, the size of the electrode tip exposure and the
     impedance cutout function of the unit limit the lesion size. Corrective action:
     the code is currently being modified so that if the temperature is ever out of
     range after the on button has been pressed and a valid temperature was
     measured the output is shuttoff. The change will be mandatory in all rfg-3c
     plus generators when they are returned for yearly calibration.


OMNI MEDICAL RADIONICS RADIOFREQUENCY                                       back to search
MACHINE                                                                             results

Model Number RFG-3C
Patient Outcome Other;
Event Description
Radionics radiofrequency machine model rfg-3c graphics rf lesion generator system.
Used for rf procedure, cervical. Demonstrated accurate self check prior to procedure.
Performed 1st level without incident. 2nd level machine guages registered inappropriate
reading at a fast, irregular rate. Procedure aborted. Subsequent cases canceled. The
device is being sent out for inspection but will be available to mfr at a later date for eval
and review.


RADIONICS INSTRUMENT DIV. RFG - 3C                                             back to search
RADIOFREQUENCY GENERATOR                                                               results

Model Number RFG-3C
Event Type Injury Patient Outcome Other;
Event Description
A user facility report was never received by radionics, for this reason, the information
that radionics has acquired on this incident is limited. It appears that trigeminal rf case
was planned on 09/24/1999 with a 30 second lesion. After the 30 seconds the timer was
reset to 30 seconds and "lesioning" continued for 3-4 cycles. Pt subsequently reported
that vision from left eye was impaired.

Manufacturer Narrative
This report is based on information supplied by others. Neither the submission of this
report or any statement made in it is intended to be an admission that any radionics
device is defective or has malfunctioned; that a death or serious injury has occurred; or
that any radionics device contributed to or is likely to contribute to a death or serious
injury if a malfunction occurred.


RADIONICS, INC. RADIONICS GROUNDING PAD                                back to search results

Model Number RF LESION GEN SYS RFG-3C
Patient Outcome Required Intervention;
Event Description
The pt was taken to the or and placed in the supine position on the operating table. The
head was rotated to the right. Radiologic marker was placed over the c2-c3 level and
oblique view was used to visualize the c2-c3, c3-c4 and c4-c5 neural foramen. Beginning
at the c2-c3 level, overlying skin was marked with surgical marker, prepped and draped
in a sterile manner. Local infiltration with 1% lidocaine. Then, using an smk-5 cannula
under oblique and a fluoroscopic guidance, the needle was directed down to the inferior
and posterior aspect of the c2-c3 neural foramen on oblique view, and seen to be in the
waist of the articular pillar of c3 on ap view. The needle was left in place. Sensory
stimulation occurred at 0-1 volt and 50 hz, with positive reproduction of the pt's pain at
approx 9. 6 volts. At this 0. 2 cc of 1. 5% lidocaine was injected. After appropriate
anesthesia, procedure proceeded with a radiofrequency lesion at 75 degrees centrigrade
for 60 seconds. The pt tolerated this well. Using the same technique as above, a second
smk-5 neelde was placed at the c4 level with a second lesion at 75 degrees centigrade for
60 seconds. Using the same technique as above, a third needle was placed at the c5 level
and on oblique view, seen to be between the c4 and c5 cervical facet joint, posterior to
the neural foramen. Sensory stimulation at 0. 3 volts reproduced the pt's typical pain at
the left shoulder and into the elbow. Motor stimulation at 2 hz and approx 2 volts was
negative for stimulation of the c5 nerve root. After appropriate anesthesia, procedures
proceeded with a third lesion at 75 degrees centigrade for 60 seconds. The pt overall
tolerated the procedure well. At the end of the cervical facet joint denervation, a
dispersing electrode pad was removed from the left upper extremity and less than a
dime-sized burn was noted at approx the center of the area where the dispersing
electrode pad had been. Surgical consultation was obtained with appropriate follow up
scheduled.


RADIONICS SERVICES & SUPPLY CO. SMK ELECTRODE KIT                                  back to
RADIOFREQUENCY LESION GENERATOR                                              search results

Model Number SMK-C/0

Event Description
Radiofrequency procedure involving the bilateral lumbar facets l3-s1 was done under
anesthesia. With the first lesion attempt, there was no elevation on the temperature gauge
that notified user that lesion was taking place. A new kit was opened, and a new
thermocoupler wire was changed to the rf generator using the same thermocoupler
introducer and there was still no temperature change. User then changed the
thermocoupler introducer and lesioning was then immediate, letting user know that the
old thermocoupler removed was defective. This thermocoupler came from the electrode
kit. The size of the thermocouple used out of this kit was smk-c10. It has not been noted
by dr that since teh recall on the needles, there has been a lot resistance in the
thermocoupler wire entering the rf smk needles when it is time to stimulate or lesion.
There have been times that these non-disposable needles would not accept the
thermocoupler and the entire needle would have to be changed. This resistance was
never a problem with the disposable needles.


RADIONICS RADIONICS UNIT R & F GENERATOR                                    back to search
(RADIOFREQUENCY) LESION                                                             results

Model Number RFG-3C
Patient Outcome Other;
Event Description
Catheter ablation procedure in progress with sedated patient. Five (5) invasive cardiac
catheters in place. Radionics unit faulted, lost power & prevented completion of
procedure. Found intermittant power due to poorly crimped spade lug terminals on
power switch. Soldered all spade lugs securely to wires invalid data - regarding single
use labeling of device. Patient medical status prior to event: invalid data. There was not
multiple patient involvement. Device serviced in accordance with service schedule. Date
last serviced: 01-oct-91. Service provided by: invalid data. Service records available. No
imminent hazard to public health claimed. Device used as labeled/intended. Device was
evaluated after the event. Method of evaluation: actual device involved in incident was
evaluated, performance tests performed. Results of evaluation: manufacturing.
Conclusion: other. Certainty of device as cause of or contributor to event: invalid data.
Corrective actions: device repaired and put back in service. Invalid data - on device
destroyed/disposed of status.



RADONICS, INC. N/A RADIOFREQUENCY LESION                                    back to search
GENERATOR                                                                           results

Model Number RFG-3AV
Patient Outcome Other;
Event Description
On januray 2, 1992. A radiofrequency lesion generator was used to perform
radiofrequency trigeminal rhizotomy. During the procedure, difficulty in maintaining the
temperature of the needle electrode was experienced. Following the procedure, the
equipment was sent to the bioengineering department to be checked. Bioengineering
found a problem with an electrode and it was replaced. Due to the absence of
instructions in the operations manual regarding checking the reliability of temperature
readings, a new procedure was developed to verify the accuracy of readings on the
generator. The patient experienced numbness post procedure, as was expected, at a
follow up exam on february 11, 1992. There was some evidence of more extensive
numbness which may be permanent, but at this point, the permanency is not conclusive.
Although the result falls within the realm of expected oucomes reasonable for this
procedure, there is the possibility that it is related to the equipment malfunciton device
not labeled for single use. Patient medical status prior to event: satisfactory condition.
There was not multiple patient involvement. Device not serviced in accordance with
service schedule. Date last serviced: 01-jan-91. Service provided by: user facility
biomedical/bioengineering department. Service records available. No imminent hazard
to public health claimed. Device used as labeled/intended. Device was evaluated after
the event. Method of evaluation: actual device involved in incident was evaluated,
electrical tests performed, performance tests performed, visual examination. Results of
evaluation: electrical problem, telemetry failure, modification of device, unanticipated
adverse reaction - long term, component failure. Conclusion: none or unknown.
Certainty of device as cause of or contributor to event: invalid data. Corrective actions:
device discarded, device repaired and put back in service, inserviced by biomedical
engineering dept. Staff. Invalid data - on device destroyed/disposed of status.


RADIONICS - TYCO REPAIR VALLEYLAB RADIONICS - TYCO back to search
RADIO FREQUENCY GENERATOR                                  results
Model Number RFG3C11760
Patient Outcome Other;
Event Description
During lesioning mode unit turned off after 10 sec. These caused cancellation of or case.
This is second time this occurred. Previously 12/2003 ship out and sent back 1/2004.
With company verifying unit functioning. Not in use again until 7/2004. When above
occurred once again.


RADIONICS RADIONICS RADIO-FREQUENCY GENERATOR                              back to search
RADIO FREQUENCY GENERATOR                                                          results

Model Number RFG-3C+(117-60)
Event Type No Answer Provided
Event Description
During initial testing the tech was doing a rf variation test; the generator failed the
temperature variation test (20% high out of specification). Troubleshooting isolated the
cause to the tc-2 cable assembly. A continuity test found that the cable had an
intermittent internal connection. The intermittent connection could not be determined at
this time. The failure with the tc-2 cable could cause an unexpected amount of energy to
be delivered to surgical site.

Manufacturer Narrative
Eval summary: condition as received by quality assurance tech. A visual inspection of
the generator found no mfg defects that would cause or contribute to the customer's
report. The generator was powered up and went through self-test to ready mode
normally. Initial testing found: during the rf variation test, the generator failed the
temperature variation test (20% high out of specification), confirming the customer's
report of the temperature shooting up. Troubleshooting isolated the cause to the tc-2
cable assembly. A continuity test found that the cable had an intermittent internal
connection. The tc-2 cable was replaced. Testing found the temperature variation test
stable after cable replacement. The cause of the intermittent connection cannot be
determined. This failure could cause an unexpected amount of energy to be delivered to
the surgical site. The generator was cycled on the bench in automatic tempertaure control
mode for a period of two hours and no problems were noted. The generator was
inspected for signs of metal to metal arcing that could cause or contribute to pt shocks
(jolt), none were found. The low frequency leakage currents were also tested and were
found to be normal and within specifications. In addition, the ground continuity was
tested and was found to be normal and within specifications. The cause of the pt jolt
cannot be determined. Radionics addresses pt stimulus (shock) in the rfg-3c plus user's
manual, (appendix b). See attached copy. The disctrode upgrade was implemented per
change order #c6921. Initial tested found that the generator functioned normally and
within specifications. The generator was placed on a chart recorder and cycled at max
power for a period of four hours (50% duty cycle) and no problems were noted. The
generator was final tested and was found to function normally and within specifications.
Service record review: a review of the service history indicates no prior service histories
are recorded for this generator.

Event Description
The generator was being used in the lesion mode when the pt experienced a jolt which
caused pt to have chest pains and shortness of breath.

Manufacturer Narrative
The returned generator failed the temperature variation test on the high side. The cause
was related to an intermittent internal connection of the tc-2 cable connection which
could cause an unexpected amount of energy to be delivered to the surgical site. The
appropriate manufacturing personnel have been made aware of this problem.



RADIONICS RFK DISPOSABLE NEEDLE ELECTRODE                            back to search results

Model Number RFK-C10D-S
Event Type Other Patient Outcome Other;
Event Description
Performed a radio frequency-lesioning in the medical branch of the dorsal root rami on a
patient at the l2-3 level. The following day the patient complained of a burning sensation
at the level of the needle entry. When the doctor brought the patient back in, it was
obvious the patient had a second degree burn present at the site of entry.

Manufacturer Narrative
This report is based on information supplied by others. Neither the submission of this
report or any statement made in it is intended to be an admission that any radionics
device is defective or has malfunctioned; that a death or serious injury has occurred; or
that any radionics device contributed to or is likely to contribute to a death or serious
injury if a malfunction occurred.

Manufacturer Narrative
No sample was received for evaluation. A review of the device history record for the
possible lot number reported by the customer showed all product passed high voltage
breakdown testing during the mfg process. Without the incident sample no conclusion
can be made. Should the incident sample be received, an evaluation will be performed
and an add'l supplemental report will be sent.
     RADIONICS RADIONICS TEW(TRIGEMINAL                                    back to search
     NEURALGIA) ELECTRODE                                                          results

     Model Number TEW
     Event Type Other
     Event Description
     During radio frequency ablation procedure. 5 mm tip of needle from the
     electrode broke off in pt's back at posterior - inferior t ii aspect of right rib.
     Physician stated it was not retrievable.

     Manufacturer Narrative
     The tew was received and evaluated visually for the cause of breakage. The
     probable cause of the break is during insertion and removal of the electrode if
     the insertion tool is not used or the tip is obstructed during removal, a kink in
     the spring tip can be formed. The kink allows the tip to catch on the tip edge
     of the cannula hampering the removal of the electrode. Excessive force is then
     needed to remove the elctrode causing the tip to become distorted and break.

1997 report
RADIONICS, INC. RRE-TM ELECTRODE RADIO FREQUENCY                                 back to search
LESIONING, ELECTRODE                                                                     results

Model Number RRE-TM
Event Type Other Patient Outcome Other;
Event Description
This event was experienced while the doctor was performing a lumbar back procedure. It
is stated in the manual that insulation is to be checked before every procedure. This
check was not done. The electrode was inserted and lesioning was done. At this point,
the doctor noticed some skin burning at the insertion site. The electrode was removed
and inspected. Insulation was noticed to be missing on the shaft near the hub. The result
was a small burn, approximately the size of a thumb tack, which required local wound
care.

Manufacturer Narrative
This is report is based on information supplied by others. Neither the submission of this
report or any statement made in it is intended to be an admission that any radionics
device is defective or has malfunctioned; that a death or serious injury has occurred; or
that any radionics device contributed to or is likely to contribute to a death or serious
injury if a malfunction occurred. Evaluation of the electrode found the insulation to be
scraped by the plastic hub. The entire shaft of the electrode was inserted during the
procedure. Because the insulation was scraped, current was allowed to pass from the
shaft into the skin causing the burn. The physician stated that the electrode was not
examined before the procedure was begun. Radionics instructions for use clearly state to
check the electrode's insulation for signs for damage before each case. If the insulation
shows breaks, the electrode instructions state that should not be used and should be sent
to radionics for recoating. No corrective action is deemed necessary at this time.
Insulation can be damaged due to handling of the electrodes. As described above, the
instructions for use clearly state to inspect the electrode insulation prior to use. The shaft
of the rre-tm electrode is bead blasted in order to roughen the surface. This allows for
better adherence of the insulation to the shaft. This electrode, rre-tm #7784, was
purchased a year and half prior to this incident and had not been returned for repair
previously.



     RADIONICS, INC. RF LESION GENERATOR                                 back to search
     SYSTEM                                                                      results

     Model Number RFG-3C
     Patient Outcome Required Intervention;
     Event Description
     Pt was in the hosp for outpatient surgery for spinal spasticity: bilateral
     percutaneous rhizotomy, bilateral sciatic rhizotomy. According to the
     physician's operative report, "a small superficial area in the right gluteal
     region had apparently received a small superficial burn from the ground lead
     which had been placed. This occurred when the radio frequency generator
     was given to complete the procedure. " report indicated, "during the
     rhizotomy procedure, machine malfunctioned during lesion phase of
     procedure. Machine utilized was an open circuit and at place where the
     ground needle inserted, pt experienced a quarter-sized burn, approx 2-3
     centimeters deep, about the depth of the ground needle. " hosp impounded the
     machine and had the machine evaluated by the hosp biomedical division.
     Following the surgical procedure, the pt was evaluated by a plastic surgeon
     who indicated there was a 3 degree burn over the sacrum area and pt was
     advised to apply silvadene topically. The size of the burn was about the size
     of a quarter. Pt and family member were shown how to apply ointment and
     given written instructions and follow-up care. Pt was discharged home. At the
     time, no contact had been made with the hosp by the pt or family member
     related to the surgical procedure or 3rd degree burn. However, the family did
     contact the surgeon indicating concern about the burn.



RADIONICS, RADIONICS RADIO FREQUENCY GENERATOR                                 back to search
ELECTROSURGICAL GENERATOR                                                              results

Model Number RFG-3C+(117-60)
Event Type Malfunction
Event Description
The customer indicated that the auto temp keeps rising by itself.

Manufacturer Narrative
Testing found that while in the automatic control mode the temperature would ramp up
too quick and overshoot. Further eval isolated the failure to the watchdog pcb where
resistors, r11 and r19 were found to be the wrong values. The resistors were replaced and
no further problems were noted. It was noted that there was a discrepancy in the test
procedure which allowed a generator to be released with the wrong value components
installed in r11 and r19 on the watchdog pcb. The test procedure has been updated to
eliminate this type of failure.

Manufacturer Narrative
The manufacturing report number has been changed from 1717344-2002-00069 to
1222895-2002-00042.


RADIONICS RADIONICS ELECTRODE                                       back to search results

Model Number RFG-3B
Patient Outcome Other;
Event Description
Radio frequency electrode tip retained below the subcutaneous tissue of left side of face
of pt in or. No plans to retrieve tip of electrode.

				
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