BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1190985 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03559
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 21, 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
    NL
    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 AN UNK PROCEDURE, THE INSTRUMENT PRODUCED A STRANGE SOUND AND WAS NOT OPTIMALLY WORKING. A PIECE OF THE INSTRUMENT WAS FOUND IN THE PT. UNK HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KASY

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR