BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 1811925 · Received August 18, 2010

    Report

    Report Number
    MW5017138
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 18, 2010
    Manufacturer
    CQ LABS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THIS REPROCESSED HARMONIC DEVICE WOULD STOP WORKING AND HAD TO BE RE TESTED AT LEAST TWICE AND THEN IT SEEMED THAT IT WOULD NOT PERFORM ITS FUNCTION WELL AT ALL FROM THEN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HARMONIC LFL CQ LABS ACE36E

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Disability