BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2883034 · Received December 7, 2012

    Report

    Report Number
    2883034
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    ACE HARMONIC (NEW) DEVICE KEPT GIVING AN ERROR CODE "RELAX BLADE PRESSURE". WAS ABLE TO FINISH CASE WITHOUT PATIENT INCIDENCE. REP PICKED UP DEVICE TO SEND BACK FOR EVALUATION. NO NEW DEVICE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC ACE36E J9235X

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR