BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2171519 · Received July 20, 2011

    Report

    Report Number
    2171519
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING FOR A LAPAROSCOPIC EXCISION OF RETROPERITONEAL LYMPH NODE PROCEDURE THE ACE HARMONIC CURVED SHEAR FAILED TO FUNCTION UPON INITIAL USE. OR STAFF ATTEMPTED TO TROUBLESHOOT ISSUE BUT DEVICE SIMPLY WOULD NOT BEGIN WORKING. DEVICE REMOVED FROM FIELD, NEW DEVICE OF SAME TYPE AND MANUFACTURER OBTAINED AND WAS USED FOR ENTIRE PROCEDURE. AFTER PATIENT TAKEN TO PACU STAFF AGAIN ATTEMPTED TO TROUBLESHOOT ISSUE BY PLUGGING INTO GENERATOR AND STILL WOULD NOT WORK. ISSUE WITH HANDPIECE, NOT CORD OR GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE36E G9L68G

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR