BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3151348 · Received May 29, 2013

    Report

    Report Number
    3151348
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING ABDOMINAL SURGERY AT THE TIME. THE SURGERY WAS INITIATED AS A LAPAROSCOPIC SURGERY, HOWEVER DUE TO THE COMPLEXITY AN ABDOMINAL INCISION NEEDED TO BE MADE. THE MD WAS USING THE HARMONIC SCALPEL AND NOTED THAT A PIECE OF THE "JAW" WAS OFF. THE PIECE WAS RETRIEVED. UNABLE TO DETERMINE IF THE PIECE WAS OFF WHEN REMOVED FROM THE PACKAGE OR NOT. THERE WAS NO HARM TO THE PATIENT DUE TO THIS DEVICE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233890 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, INC. * J92M94

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR