BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP / EMS

    MDR report key: 747178 · Received November 1, 2005

    Report

    Report Number
    MW1037070
    Event Type
    Other
    Date Received
    November 1, 2005
    Report Date
    November 1, 2005
    Manufacturer
    ALLEGIANCE EMS
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE INSULATION ON "SHEERS" GAVE THE PATIENT A 1.5 CM BURN ON MUSCLE TISSUE AND LEFT A SMALL BURN ON TIP OF TROCAR IT FED THROUGH. THE INSULATION DID APPEAR TO BE INTACT. IT DID HAVE A SLEEVE OVER THE AREA LIKE A PREVIOUS REPAIR, THIS SLEEVE BURNED AND WAS MELTED APPEARING. NO PATIENT TREATMENT WAS NEEDED AS BURNED AREA WAS SAME TYPE OF TISSUE THAT WOULD HAVE BEEN AFFECTED HAD A BLEEDER BEEN BOVIED. THE BURNED AREA WAS IN MUSCLE AREA AND DID NOT AFFECT CRUCIAL AREAS SUCH AS DIAPHRAGM OR BOWEL. EQUIPMENT AND INSTRUMENTS ARE VENDOR OWNED AND MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP / EMS SHEARS - LAPAROSCOPIC SCISSORS LRW ALLEGIANCE EMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SHEARS - PART OF LAPAROSCOPY GENERAL SET.