BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2031827 · Received March 25, 2011

    Report

    Report Number
    2031827
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 25, 2011
    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

    NOT WORKING PROPERLY - WHEN DEPRESSING BUTTON, IT WAS ONLY WORKING INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS * 1458304

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR