BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDVAC SMOKE EVACUATION PENCIL WITH ROCKER SWITCH

    MDR report key: 4131556 · Received October 1, 2014

    Report

    Report Number
    3007305485-2014-00091
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K081634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE DEVICE TO CONMED CORPORATION IS ANTICIPATED; HOWEVER, TO DATE THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER'S COMPLAINT HANDLING CENTER. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) "UNOPENED" SAMPLES OF CATALOG NUMBER 60-7580-005 GOLDVAC ROCKER SWITCH SMOKE EVACUATION PENCILS WERE RETURNED TO CONMED FOR EVALUATION. (B)(4) OF THESE "UNOPENED" SAMPLES WERE EVALUATED REGARDING THIS MEDWATCH. THESE "UNUSED" DEVICES ARE LOT REPRESENTATIVE PRODUCTS AND NOT THE ACTUAL ALLEGED FAILURE DEVICE. EACH DEVICE WAS ELECTRICALLY TESTED USING AN ELECTROSURGICAL GENERATOR FOR CUT AND COAG. NO AUTO ACTIVATION, CONTINUOUS ACTIVATION OR ANY OTHER UNINTENDED ACTIVATION WAS OBSERVED DURING TESTING WITH ANY OF THE (B)(4) RETURNED LOT SAMPLE DEVICES. THE ADDITIONAL (B)(4) LOT SAMPLES WERE EVALUATED UNDER MEDWATCH 3007305485-2014-00090 FROM THE SAME END-USER FACILITY. THESE DEVICES WERE MANUFACTURED 14-MAR-2014. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED INCIDENT. OF THE LOT CONTAINING 600 UNITS, THERE WAS ONE (1) OTHER SIMILAR COMPLAINT RECEIVED FROM THE SAME END-USER FACILITY WITH A SIMILAR REPORTED INCIDENT AND ADVERSE OUTCOME. A 2-YEAR REVIEW OF THE COMPLAINT HISTORY SHOWS (B)(4) SIMILAR REPORTS FOR AUTO ACTIVATION/REMAINS ACTIVE, FOR THE GOLDVAC PENCIL DEVICE FAMILY. OF THESE (B)(4) RECEIVED REPORTS ONLY (B)(4) REPORTED INCIDENTS FROM THIS END-USER FACILITY RESULTED IN "BURN/CUT TO THE PATIENTS" (SEE MDR NUMBER 3007305485-2014-00090). REPORTEDLY, THE BURNS/CUTS OCCURRED WHEN THE SURGEONS PLACED THE DEVICES ON THE PATIENTS INSTEAD OF THE RECOMMENDED HOLSTERS WHILE THE UNITS WERE ALLEGEDLY "STUCK" IN THE ACTIVATION POSITION. THE (B)(4) CONMED SYSTEM 5000 ESUS (ELECTROSURGICAL UNITS - SERIAL NUMBERS: (B)(4)) USED WITH THESE TWO REPORTED EVENTS FROM THIS END-USER FACILITY HAVE BOTH BEEN RETURNED TO THE CONMED SERVICE CENTER IN (B)(6) FOR EVALUATION. COMPLETE TESTING OF THE ESUS WAS DONE AND FOUND BOTH UNITS PERFORMED TO SPECIFICATIONS AND PASSED ALL FUNCTIONAL TEST REQUIREMENTS PER CONMED'S TESTING PROTOCOLS. THE GOLDVAC PENCILS ARE DESIGNED TO BE USED IN CONJUNCTION WITH CONMED GOLDVAC ULTRACLEAN ELECTRODES. THE GOLDVAC PENCIL ENABLES THE OPERATOR TO REMOTELY CONDUCT AN ELECTROSURGICAL CURRENT FROM THE OUTPUT CONNECTOR OF AN ELECTROSURGICAL UNIT TO THE OPERATIVE SITE FOR THE DESIRED SURGICAL EFFECT. IN THIS REPORTED EVENT, AS WELL AS THE SECOND SIMILAR EVENT RECEIVED FROM THIS END-USER FACILITY, THE PHYSICIAN PLACED THE GOLDVAC PENCIL ONTO THE SURGICAL DRAPE ON TOP OF THE PATIENT. NO HOLSTER WAS UTILIZED FOR THE DEVICE WHEN IT WAS NOT IN USE IN THE PROCEDURE. IT WAS ALSO REPORTED, IN EACH CASE, THAT THE PHYSICIAN DID NOT HEAR THE ESU ACTIVATION TONE THAT IS EMITTED WHEN THE ELECTROSURGICAL PENCIL IS IN THE ACTIVATION MODE. IN REGARDS TO THE ACTIVATION TONE OF THE ESUS, IT WAS NOTED BY THE SERVICE TECHNICIAN WHO EVALUATED AND SERVICED THESE ESUS AFTER THE INCIDENTS INDICATED THAT THE ACTIVATION TONE, ON EACH ESU, WAS SET ON THE MINIMUM SETTING FOR THE ACTIVATION TONE. THE MINIMUM ACTIVATION TONE OF THE SYSTEM 5000 ESU IS BARELY AUDIBLE IN A QUIET, EMPTY OPERATING SUITE. IN THIS INSTANCE, THE ACTIVATION TONE VOLUME, AS FOUND ON THE MINIMUM SETTING THAT MOST LIKELY WOULD NOT HAVE BEEN AUDIBLE TO THE SURGEONS IN AN OCCUPIED, BUSY OPERATING ROOM SUITE. THE SYSTEM 5000 USER MANUAL STATES IN SECTION 2.0 INSTALLATION AND OPERATION, 2.3.1 PRELIMINARY FUNCTIONAL TESTING: "THE FOLLOWING CHECKS ARE RECOMMENDED UPON INITIAL INSTALLATION OF THE EQUIPMENT AND PRIOR TO EACH USE OF THE INSTRUMENT TO AVOID UNNECESSARY DELAYS IN SURGERY. #15. CONNECT A HAND CONTROLLED ACCESSORY TO ONE OF THE MONOPOLAR ACCESSORY RECEPTACLES. ACTIVATE THE CUT AND COAG BUTTONS ON THE ACCESSORY, ONE AT A TIME, VERIFYING THAT EACH CONTROL CAUSES THE CORRECT INDICATOR AND TONE TO SOUND". THE AORN (ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES) PERIOPERATIVE STANDARDS AND RECOMMENDED PRACTICES, RECOMMENDED PRACTICES FOR ELECTROSURGERY, RECOMMENDATION IV, PARAGRAPH 4 READS: "AUDIBLE ACTIVATION INDICATOR(S) AND ALARMS SHOULD BE PRESENT AND LOUD ENOUGH TO BE HEARD ABOVE OTHER SOUNDS IN THE OR. THE VOLUME OF THE ACTIVATION INDICATOR SHOULD BE MAINTAINED AT AN AUDIBLE LEVEL TO IMMEDIATELY ALERT PERSONNEL WHEN THE ESU IS ACTIVATED INADVERTENTLY". IN ADDITION, THE IFU FOR THE GOLDVAC PENCIL STATES UNDER SAFETY TIPS: "ALWAYS PLACE UNUSED ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION SUCH AS THE PROVIDED HOLSTER WHEN NOT IN USE". THE SYSTEM 5000 USER MANUAL FURTHER STATES IN SECTION 1.1.1 CAUTIONS FOR EQUIPMENT PREPARATION: "UNUSED ACCESSORIES SHOULD BE STOWED IN A SAFE, ELECTRICALLY INSULATED PLACE SUCH AS A NONCONDUCTIVE HOLSTER, ISOLATED FROM THE PATIENT". THIS OPERATOR MANUAL FURTHER STATES IN SECTION 1.1.3 CAUTIONS FOR USE: "SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO ON FACTORS UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT THAT THE INSTRUCTIONS SUPPLIED WITH THIS EQUIPMENT BE READ, UNDERSTOOD, AND FOLLOWED IN ORDER TO ENSURE SAFE AND EFFECTIVE USE OF THE EQUIPMENT". TO REDUCE THE RISK OF PATIENT/USER INJURY THE INSTRUCTION FOR USE (IFU) OF THE GOLDVAC PENCIL PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: ALWAYS PLACE UNUSED ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION SUCH AS THE PROVIDED HOLSTER WHEN NOT IN USE. THE GOLDVACD PENCILS ARE NOT INTENDED TO SUCTION FLUIDS FROM THE SURGICAL SITE. USE THE LOWEST POSSIBLE SETTING ON THE ASSOCIATED ELECTROSURGICAL UNIT CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. ACTIVATION TIME SHOULD BE AS SHORT AS POSSIBLE. NEVER ALLOW CABLES CONNECTED TO THESE DEVICES TO BE IN CONTACT WITH SKIN OF THE PATIENT OR THE OPERATOR DURING ELECTROSURGICAL ACTIVATIONS. DO NOT PERMIT CABLES CONNECTED TO THESE DEVICES TO BE PARALLEL AND IN CLOSE PROXIMITY TO THE LEADS OF OTHER ELECTRICAL DEVICES. INSPECT AND TEST EACH DEVICE BEFORE USE. THESE DEVICES SHOULD BE INSPECTED BEFORE EACH USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE INCLUDING: CRACKED, BROKEN, OR OTHERWISE DISTORTED PLASTIC PARTS. BROKEN OR SIGNIFICANTLY BENT CONNECTOR CONTACTS. DAMAGE INCLUDING CUTS, PUNCTURES, NICKS, ABRASIONS, UNUSUAL LUMPS, OR SIGNIFICANT DISCOLORATIONS. VERIFY THAT THE ELECTRODE IS FULLY AND SECURELY SEATED IN THE PENCIL BEFORE USE. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 3007305485-2014-00090 FROM THE SAME END-USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE GOLDVAC ELECTROSURGICAL PENCIL IN A MASTECTOMY PROCEDURE WITH EXPANDER IMPLANTS, THE PATIENT SUSTAINED A CUT/BURN. IT WAS REPORTED THAT THE PHYSICIAN PLACED THE GOLDVAC ELECTROSURGICAL PENCIL ON THE PATIENT WHILE THE CUT FUNCTION WAS STUCK IN THE ACTIVATION POSITION THAT RESULTED IN A 2 CM BURN/CUT ON THE UPPER PORTION OF THE BREAST. NO HOLSTER WAS UTILIZED FOR THE DEVICE WHEN IT WAS NOT IN USE IN THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PHYSICIAN DID NOT HEAR THE ESU MACHINE ACTIVATION TONE THAT IS EMITTED WHEN THE ELECTROSURGICAL PENCIL IS IN THE ACTIVATION MODE. THE END-USER BIO-MEDICAL DEPARTMENT HAS THE ESU IN QUARANTINE FOR THEIR EVALUATION AND WILL CONFIRM WITH CONMED CORPORATION THE VOLUME SETTING OF THE ACTIVATION TONE ON THEIR EVALUATION. THE 2CM BURN/CUT WAS SUTURED CLOSED BY THE PHYSICIAN AND THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED. NO OTHER COMPLICATIONS FROM THE BURN/CUT OR ANY LONG TERM ADVERSE EFFECTS HAVE BEEN REPORTED BY THE END-USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611252 GOLDVAC SMOKE EVACUATION PENCIL WITH ROCKER SWITCH GOLDVAC PENCIL GEI CONMED ELECTROSURGERY 1403143

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention CONMED SYSTEM 5000 ELECTROSURGICAL UNIT, ESU