BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1993442 · Received February 15, 2011

    Report

    Report Number
    1993442
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    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

    PHYSICIAN WAS USING THE DEVICE AND STOPPED WORKING FROM THE HAND CONTROLS - HE CONTINUED BY USING THE FOOT PEDAL.THE REP FROM ETHICON INSPECTED THE UNIT, BUT WAS UNABLE TO REPRODUCE THE PROBLEM. MAYBE AN INTERMITTENT ISSUE. ETHICON WILL SCHEDULE AN INSERVICE WITH STAFF. THE REP WILL PICK UP DEVICE ON HIS RETURN VISIT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE36E G9L80M

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR