BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2903488 · Received January 4, 2013

    Report

    Report Number
    2903488
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC STOPPED WORKING, CORD WAS CHANGED WITH NO RESULTS. MACHINE STATED "REPLACE INSTRUMENT." HANDPIECE WAS CHANGED WITH IMMEDIATE RESULTS. NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5196 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY REF ACE14S J4CF0E

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR