BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2924995 · Received December 27, 2012

    Report

    Report Number
    2924995
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHITE INSULATION ON JAW FELL OFF DURING A LAPAROSCOPIC DONOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR NO OTHER THERAPIES