BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1182731 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03769
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 2, 2008
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/17/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, UPON TESTING THE INSTRUMENT AFTER SET UP, THE HAND ACTIVATED BUTTONS WOULD NOT WORK. THE DEVICE WAS FUNCTIONAL VIA FOOT PEDAL ACTIVATION. THE DEVICE WAS CHANGED FOR A NEW ONE, WHICH RESOLVED THE PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KNOG

    Patients

    Seq Age Sex Outcome Treatment
    1 HAND PIECE| GENERATOR