BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1942633 · Received December 21, 2010

    Report

    Report Number
    1942633
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE HARMONIC SCALPEL HANDPIECE FOR A SYMPATHECTOMY, THE HAND PIECE WOULD MALFUNCTION PERIODICALLY NECESSITATING THE RESTARTING OF THE MACHINE. IT WOULD THEN FUNCTION FOR A FEW MORE MINUTES THEN REQUIRE RESETTING AGAIN. THE SURGERY WAS COMPLETED WITH THIS EQUIPMENT AND NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS * 1270964

    Patients

    Seq Age Sex Outcome Treatment
    1 *