BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3042261 · Received March 18, 2013

    Report

    Report Number
    3042261
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO WORK HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE. HAND CONTROL AND TORQUE WRENCH DID NOT WORK AFTER CONNECTED TO THE GENERATOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112257 HARMONIC ACE INSTRUMENT, ULTRASONIC, SURGICAL LFL ETHICON ENDO-SURGERY, INC. * J4A809

    Patients

    Seq Age Sex Outcome Treatment
    1 *