BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3812007 · Received May 9, 2014

    Report

    Report Number
    3812007
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WOULD NOT REGISTER WHEN HOOKED UP TO THE CORD AND MACHINE. STAFF CHANGED THE DEVICE AND IT WORKED JUST FINE. ITEM WILL BE RETURNED WHEN THE SHIPPING CONTAINER IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281304 HARMONIC ACE INSTRUMENT, ULTRASONIC, SURGICAL LFL ETHICON ENDO-SURGERY, INC. * L9013D

    Patients

    Seq Age Sex Outcome Treatment
    1 *