BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3231170 · Received July 8, 2013

    Report

    Report Number
    3231170
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE LAPAROSCOPIC SHEARS - THE HARMONIC PIECE WOULD NOT ROTATE. WHEN THE SURGEON TRIED TO ROTATE IT FIRMLY, THE HANDLE UNSCREWED FROM THE REUSEABLE HANDPIECE WITH CORD. REUSEABLE HANDPIECE WITH CORD WAS SWITCHED OUT AND THE SAME THING HAPPENED, SO A NEW DISPOSABLE HAND PIECE WAS OPENED, AND WORKED CORRECTLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SURGICAL PROCEDURE LEFT LAPAROCOPIC RADICAL NEPHRECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310747 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, INC. * K9010R

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR