BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS SCALPEL

    MDR report key: 1182464 · Received September 19, 2008

    Report

    Report Number
    1182464
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 8, 2008
    Report Date
    September 20, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE HAND PIECE OF THE HARMONIC SCALPEL FAILED TO WORK APPROPRIATELY. THE WHITE INSERT ON THE JAWS OF THE INSTRUMENT SLIDES UP AND DOWN. THIS IS NOT NORMAL FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS SCALPEL SCALPEL, HARMONIC LFL ETHICON ENDO-SURGERY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR