BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1823744 · Received December 11, 2007

    Report

    Report Number
    1527736-2007-08410
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 28, 2007
    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
    UK
    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 RIGHT HEMI COLECTOMY, THE HAND ACTIVATION BUTTONS ON THE DEVICE WERE NOT WORKING. SURGEON USED THE FOOT PEDAL AND THIS WORKED FINE. PROCEDURE WAS COMPLETED WITH THE SAME LIKE DEVICE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4JA57

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE