BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION

    MDR report key: 3212358 · Received July 5, 2013

    Report

    Report Number
    3212358
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE INITIALLY FUNCTIONED AS EXPECTED AND THEN STOPPED WORKING. ALERTING NOISE SOUNDED FROM HARMONIC MACHINE AND INDICATED: CLEAN, TIGHTEN, RETEST. THEN DEVICE INDICATED: REMOVE AND DISPOSE. DEVICE WAS REMOVED FROM FIELD. NEW DEVICE OPENED. PROCEDURE CONTINUED WITHOUT HARM TO THE PATIENT OR STAFF.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307087 ULTRACISION INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC * K4CG03

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR