BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3082335 · Received April 9, 2013

    Report

    Report Number
    3082335
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING A HARMONIC ACE36E HANDPIECE AND NOTICED THE WHITE PIECE ON THE TIP WAS FALLING APART. DEFECTIVE PRODUCT WAS PULLED FROM THE FIELD AND A SECOND HANDPIECE WAS OPENED TO COMPLETE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC NEPHRECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148068 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL STERILMED, INC. ACE36E JOB. NO. 1485137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR