BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1923976 · Received December 6, 2010

    Report

    Report Number
    1923976
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HAND CONTROL WOULD NOT WORK: SWITCH MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE36 G9KZ4Y
    2 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ACE36 G9L251

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR