BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1946103 · Received December 30, 2010

    Report

    Report Number
    1946103
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    September 14, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN FOR LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. THE HARMONIC SCALPEL "CURVED SHEARS WITH ERGONOMIC HANDLE HAND CONTROL AND TORQUE WRENCH" WAS BEING USED. THE SURGEON STATED IT WAS WORKING INTERMITTENTLY AND DESIRED TO SWITCH HAND PIECES OUT. NO HARM CAME TO PATIENT PER SURGEON. DEFECTIVE HARMONIC HANDPIECE REMOVED FROM FIELD AND GIVEN TO MANAGER TO FOLLOW UP. REPLACEMENT HARMONIC WORKED CORRECTLY.

    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 G9KP0L

    Patients

    Seq Age Sex Outcome Treatment
    1 *