BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECH-SWITCH

    MDR report key: 64560 · Received January 16, 1997

    Report

    Report Number
    1720159-1996-00084
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    December 1, 1996
    Report Date
    January 16, 1997
    Manufacturer
    CONMED CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "CUT AND COAG BUTTONS FAILED TO WORK. WHEN UNIT WAS PLUGGED IN, THE BLADE WAS ALREADY LIVE." WAS RECEIVED 12/20/96. THE LOT NUMBER FOR THE INCIDENT DEVICE WAS NOT AVAILABLE HOWEVER THE DEVICE WAS RECEIVED AT CO FOR EVALUATION 3/3/97. A MALFUNCTION MDR WAS FILED WITH THE FDA SINCE THERE WAS NO INDICATION THAT AN INJURY HAD OCCURRED HOWEVER THE INCIDENT DESCRIPTION INDICATES A REOCCURRENCE COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. EXAMINATION OF THE DEVICE BY CO INDICATED THAT THE PENCIL HAS BEEN USED MULTIPLE TIMES SINCE THE ELECTRODE HAD BEEN SCRAPPED CLEAN AND THE PLASTIC CONNECTOR BODY EXHIBITED A SLIGHT COLOR CHANGE CONSISTENT WITH STEAM STERILIZATION. TESTING WAS PERFORMED WITH AN OHMMETER AND A SABRE 2400 WITH NO INDICATION OF THE DESCRIBED PROBLEM, THERE WAS NO INDICATION OF THE "LIVE BLADE" AND THE BUTTONS ACTIVATED THE PENCIL AS EXPECTED. THE PENCIL BODY WAS OPENED AS WELL AS THE CONNECTOR AND NO CONDITION WAS OBSERVED WHICH MIGHT EXPLAIN WHY THE BLADE WAS "LIVE". IT WAS OBSERVED THAT THE PWB HAD SOME SURFACE DISCOLORATION, AGAIN AS AN EXPECTED RESULT OF MULTIPLE STEAM STERILIZATION CYCLES, HOWEVER THE ELECTRODE COLLET HAD FRACTURED ITS SOLDER JOINT ON THE PWB. THE COLLET WAS MAKING MECHANICAL CONTACT AND ALTHOUGH OCCASIONALLY INTERMITTENT, THIS WAS NOT LIKELY A FACTOR IN THE ABOVE DESCRIBED INCIDENT. TESTING CONDUCTED PREVIOUSLY ON SIMILAR DEVICES HAVE HAD NO SAMPLES WHICH EXHIBIT THE SYMPTOM OF "BLADE BEING LIVE" WITH NO ACTIVATION. SINCE ALL TESTING RESULTS WERE NEGATIVE AND NO CONDITION WAS OBSERVED WHICH WOULD EXPLAIN THIS SYMPTOM, NO CONCLUSION COULD BE MADE AS TO ITS ROOT CAUSE.

    Description of Event or Problem · 1

    CUT AND COAG BUTTONS FAILED TO WORK ON ONE DEVICE, AND WHEN THE UNIT WAS PLUGGED IN THE BLADE WAS ALREADY LIVE. THIS IS ALSO UNACCEPTABLE AND AN URGENT REPLY WOULD BE MOST APPRECIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECH-SWITCH ELECTROSURGICAL PENCIL GEI CONMED CORP TECH-SWITCH PENCIL, REUSABLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA E.S. GENETRATOR