BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY

    MDR report key: 1803016 · Received August 11, 2010

    Report

    Report Number
    MW5017094
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ETHICON ENDOSURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER THE EVENT REPORT, "HARMONIC WASN'T CUTTING. WE CHANGED THE HARMONIC HANDPIECE AND THE CORD PER DR (B)(6) ORDER AND THEN THE HANDPIECE WORKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY HARMONIC ACE 45E LFL ETHICON ENDOSURGERY, INC. ACE45E G4RZ5M

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR