BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HHARMONIC ACE 36 CM

    MDR report key: 1782115 · Received February 12, 2008

    Report

    Report Number
    1527736-2008-00836
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 29, 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
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP NISSEN PROCEDURE, THE HAND ACTIVATION BUTTONS WERE NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HHARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JT14

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR