BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1152703 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03700
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    May 27, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMA PROCEDURE, THE BLADE BROKE AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE CASE. 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 E4KA3U

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR