BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3073118 · Received April 17, 2013

    Report

    Report Number
    3073118
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STERILMED
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    "DOUBLE ACTIVATION" ERROR OCCURRED WHEN THE REPROCESSED HARMONIC HANDPIECE WAS NOT RECOGNIZED BY THE HARMONIC BASE. A SECOND HANDPIECE WAS OPENED AND USED TO COMPLETE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166659 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL STERILMED ACE36E JOB# 1564965

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR