BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1781427 · Received August 1, 2010

    Report

    Report Number
    1781427
    Event Type
    Malfunction
    Date Received
    August 1, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING A 36CM LONG HARMONIC ACE HAND PIECE, THE WHITE PLASTIC AT THE TIP OF THE GRASPER CAME OFF. IT WAS RECOVERED AND REMOVED FROM THE PATIENT BY THE SURGICAL TEAM. ANOTHER HARMONIC HAND PIECE WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE HARMONIC ACE HAND PIECE LFL ETHICON ENDO-SURGERY N/A G9JG4V

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR