BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1080020 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00570
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 19, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY PROCEDURE, THE HAND ACTIVATION DIDN'T WORK; THE DEVICE WAS CONTROLLED WITH THE PEDAL SWITCH FUNCTION. IT WORKED FOR FEW MINUTES AND THEN THE DEVICE FAILED TO FUNCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC. NA D4JP42

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE