BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2031828 · Received March 25, 2011

    Report

    Report Number
    2031828
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MELTED FAT TISSUE BUT DID NOT SEAL BLOOD VESSELS.

    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 G9LK4K

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR