BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE+

    MDR report key: 3250775 · Received July 25, 2013

    Report

    Report Number
    3250775
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    April 16, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE NEW VERSION OF THE ETHICON HAMONIC ACE WAS USED IN THE CASE. WHEN THE SHEARS TOUCHED UP AGAINST THE STAINLESS STEEL OF THE RUMI IT CAUSED THE ACE HANDPIECE TO MALFUNCTION. THE ACE WOULD NOT CUT TISSE WHEN SENDING SIGNAL BACK TO POWER UNIT. THE HANDPIECE HAD TO BE REPLACED WITH THE PREVIOUS GENERATION (VERSION).WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349372 HARMONIC ACE+ INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, INC. * J9327Z

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR