BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1823702 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07685
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 26, 2007
    Report Date
    November 5, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP TOTAL HYSTERECTOMY PROCEDURE, THE HAND ACTIVATION BUTTONS STOPPED WORKING. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4J45P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE