BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 23 CM

    MDR report key: 1163140 · Received September 17, 2008

    Report

    Report Number
    3005075853-2008-01758
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 21, 2008
    Manufacturer
    EHTICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY, THE INSULATING SHEATH OF THE TISSUE PAD BROKE. EXCESSIVE THERMAL TRANSMISSION CAUSED, SEVEN DAYS LATER, A PERFORATION OF THE COLON. THEREFORE, THE PATIENT HAD TO UNDERGO A SECOND SURGERY TO REPAIR THE BOWEL. ONE DEVICE IS CURRENTLY UNDER LEGAL HOLD AND WILL BE SENT FOR EVALUATION AFTER THIS 30-DAY PERIOD EXPIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23 CM LFL EHTICON ENDO-SURGERY, LLC. NA E4L86C

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GENERATOR| AND HANDPIECE