BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HARMONIC ACE

    MDR report key: 1904268 · Received November 18, 2010

    Report

    Report Number
    1904268
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO HAND CONTROLS - WOULD NOT WORK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS * 1207861

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR