BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL

    MDR report key: 1232623 · Received November 10, 2008

    Report

    Report Number
    1232623
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE HANDPIECE STOPPED FUNCTIONING WHILE IT WAS IN USE ON THE PATIENT. THE HARMONIC GENERATOR WAS TURNED OFF AND ON TO RESET THE NEW HANDPIECE, TESTED, AND THE CASE PROCEEDED WITHOUT INCIDENT.THE HARMONIC GENERATOR WAS TESTED AND FOUND TO BE FUNCTIONING APPROPRIATELY. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HARMONIC SCALPEL LFL ETHICON ENDO-SURGERY, INC. * CE0123

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR