BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1964462 · Received January 12, 2011

    Report

    Report Number
    1964462
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COULD NOT GET DEVICE TO WORK AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS ACE36E 1355761

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR