BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SYNERGY

    MDR report key: 2163320 · Received July 12, 2011

    Report

    Report Number
    2163320
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 20, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    A SELF-TEST WAS CONDUCTED ON THIS DISPOSABLE HANDPIECE PRIOR TO USE AND IT FAILED. THIS IS THE FOURTH HANDPIECE TO FAIL THE SELF-TEST. THE FAILED HANDPIECES WERE RETURNED TO THE MANUFACTURER VIA THE LOCAL REPRESENTATIVE AND WERE REPLACED AT NO ADDITIONAL CHARGE TO THE FACILITY. THERE WAS NO PATIENT INJURY DUE TO THESE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SYNERGY INSTRUMENT, ULTRASONIC SURGICAL, COMBINATION HOOK BLADE LFL ETHICON ENDO-SURGERY, INC. * A95116P00

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES