BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2771532 · Received September 4, 2012

    Report

    Report Number
    2771532
    Event Type
    Malfunction
    Date Received
    September 4, 2012
    Date of Event
    August 6, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC SCALPEL HANDPIECE INSTRUMENT IS NOT WORKING. THE MACHINE KEEPS SAYING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, INC. * J91268

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR