BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3893469 · Received June 2, 2014

    Report

    Report Number
    3893469
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ETHICON LAPAROSCOPIC HARMONIC SHEARS WERE BEING TESTED (PRIOR TO PATIENT USE). THE HANDLE WOULD LOCK UP AND NOT TURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322521 HARMONIC ACE INSTRUMENT,ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC * L90C8L

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NO OTHER THERAPIES