BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1904265 · Received November 17, 2010

    Report

    Report Number
    1904265
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THIS PIECE OF EQUIPMENT INTRAOPERATIVELY, THE MACHINE ALERTED THAT IT WAS NOT FUNCTIONING PROPERLY. IT WAS THEN TAKEN OUT OF THE PATIENT AND TESTED AND THE JAWS WERE WIPED WITH A 4X4 SPONGE. AFTER THE JAWS WERE CLEANED IT WAS NOTICED THAT A PIECE HAD BROKEN OFF AND WAS LEFT BEHIND IN THE 4X4. THE INSTRUMENT AND BROKEN PIECE WERE REMOVED FROM THE FIELD

    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 G9L046

    Patients

    Seq Age Sex Outcome Treatment
    1 *