BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2181652 · Received July 25, 2011

    Report

    Report Number
    2181652
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM STAFF REPORT THAT, DURING A LAP BAND PROCEDURE, WHILE USING THE HARMONIC SCALPEL, IT WAS NOTICED THAT THE TIP OF THE INSTRUMENT WAS COMING APART. THE MATERIAL COVERING ONE SIDE OF THE JAW PIECE HAD COME LOOSE. DEVICE IS STILL INTACT, BUT PIECE LOOKED AS IF IT COULD FALL INTO PATIENT'S ABDOMEN AT ANY TIME. DEVICE REMOVED FROM FIELD, SEQUESTERED FOR REPORTING/EVALUATION PURPOSES. NEW DEVICE OF SAME TYPE/MODEL, BUT WITH A DIFFERENT LOT NUMBER, USED TO FINISH PROCEDURE WITH NO FURTHER ISSUES NOTED. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE45E H43P7P

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR