BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1080462 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00416
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, WHILE TESTING THE DEVICE, IT DID NOT WORK WHILE PRESSING THE BUTTONS. SURGERY WAS PROLONGED 5 MINUTES. THE DEVICE WAS CHANGED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM NONE LFL ETHICON ENDO-SURGERY, LLC NA E4KN0C

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR