BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2081152 · Received May 3, 2011

    Report

    Report Number
    2081152
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON ENGAGED THE HARMONIC SCALPEL HANDPIECE. ONCE TISSUE WAS CAUTERIZED, THE SCALPEL CONTINUED TO FIRE. THE SURGEON REMOVED HIS HAND FROM THE TRIGGER AND THE HANDPIECE CONTINUED TO FIRE. THE OR STAFF PUSHED THE HAND ACTIVATION BUTTON ON UNIT TO DISABLE AND TURNED MACHINE OFF.ASCENT WOULD LIKE TO OBTAIN DEVICE FOR INSPECTION AND TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS ACE 36E 1510331

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR