BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC

    MDR report key: 3070293 · Received March 25, 2013

    Report

    Report Number
    3070293
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 25, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARGON BEAM COAGULATOR-HAND PIECE WITH BUTTONS IN USE (NO FOOT PEDAL) WAS RESTING IN POCKET OF BLUE OR DRAPE (PER USUAL USE). THE ARGON BEAM FIRED SPONTANEOUSLY, BURNING THROUGH THE DRAPE AND THE SURGEON'S GOWN AND SCRUB PANTS. SURGEON AND STAFF REPORT THAT NO ONE WAS TOUCHING THE ARGON BUTTONS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ORTHOTOPIC LIVER TRANSPLANT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122552 ABC ELECTROSURGICAL, HANDSWITCHING PENCIL, ARGON BEAM GEI CONMED CORPORATION 130321 *
    122576 SYSTEM 7550 ABC ELECTROSURGICAL, GENERATOR, ARGON BEAM GEI CONMED CORPORATION 7550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR CARDIAC DRUGS| LIGASURE, ARGON BEAM, AND SUTURE LIGATURES