BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 899897 · Received August 16, 2007

    Report

    Report Number
    MW5003467
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2007, 12:58 PM TIP OF DISPOSABLE HARMONIC SHEARS APPEARED TO SMOKE AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE GENERAL SURGERY PRODUCT LFL ETHICON ENDO-SURGERY, INC D4H37J

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other