BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4817628 · Received May 29, 2015

    Report

    Report Number
    4817628
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    DURING LAP CHOLE; UMBILICAL HERNIA REPAIR WITH DOCTOR, THE MONOPOLAR CABLE BLEW APART AND A SPARK FLEW UP TOWARDS DOCTOR'S FACE, CAME BACK DOWN, AND LANDED ON THE DRAPE. THE DRAPE WAS CHARRED. THE DRAPE WAS CHECKED FROM THE UNDERSIDE AND IT DID NOT BURN THROUGH THE DRAPE. ALL PIECES, HOOK CAUTERY, FORCE FX, AND MONOPLAR CORD WERE IMMEDIATELY REMOVED FROM THE FIELD/ROOM AND SEQUESTERED. PER REPORTER,THE MANUFACTURER REQUESTED MORE INFORMATION AND ARE INVESTIGATING THE INCIDENT.THE REP TOLD THE SURGERY DIRECTOR THAT THESE CORDS CAN ONLY BE USED FOR TWO YEARS. THE DIRECTOR DOES NOT RECALL EVER BEING TOLD THIS AND THERE IS NOTHING ON THE PACKING OR INSERTS STATING THIS. SURGERY PULLED ALL CORDS AND AND THE BATCH NUMBERS ARE 504/094, 330/654, 251/938, 110/196, 935/071, 211/990. ALL HAVE BEEN REPLACED WITH NEW CORDS AND ARE NOW ON ROTATION TO CHANGE OUT EVERY TWO YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350431 * CABLE, ELECTROSURGICAL, CUTTING, COAGUATION GEI RICHARD WOLF MEDICAL INSTRUMENTS CORP 8106-033 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR