BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2123683 · Received June 10, 2011

    Report

    Report Number
    2123683
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE ON A PEDIATRIC PATIENT, SURGEONS WERE USING A HANDPIECE FOR THE HARMONIC SCALPEL (CURVED SHEARS WITH ERGONOMIC HANDLE, HAND CONTROL AND TORQUE WRENCH) WHEN THE INSULATING PORTION OF THE JAWS BROKE. THE SURGEON NOTICED THE SITUATION RIGHT AWAY AND STOPPED USE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE36E G9LA46

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR