BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1821099 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05253
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 25, 2007
    Report Date
    July 26, 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
    FR
    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 COLECTOMY PROCEDURE THE HAND SWITCH ON THE DEVICE WAS DEFECTIVE. THE SITE USED THE FOOT SWITCH TO COMPLETE THE CASE WITH THE SAME DEVICE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4H11Z

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR