BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2943725 · Received January 23, 2013

    Report

    Report Number
    2943725
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    DURING LSH PROCEDURE HARMONIC HANDLE WOULD NOT WORK. ERROR MESSAGE: "TIGHTEN HANDLE." RE-ASSEMBLED AND ERROR MESSAGE CONTINUED. NEW DEVICE OPENED. CASE PROCEEDED WITHOUT INCIDENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32652 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO SURGERY * J92F25

    Patients

    Seq Age Sex Outcome Treatment
    1 *