BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1022737 · Received March 24, 2008

    Report

    Report Number
    1527736-2008-01776
    Event Type
    Death
    Date Received
    March 24, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A ESOPHAGEAL HIATAL HERNIA WHEN BLEEDING WAS CONFIRMED FROM SOMEWHERE. THE DEVICE HAD BEEN USED TO SEPARATE TISSUES DURING THIS PROCEDURE. SURGEON COMMENTED THAT THE DEVICE HAD NO PROBLEM ABOUT IT'S FUNCTION AND USAGE. WHEN THE SURGEON FOUND THE BLEEDING SOMEWHERE OF THE LESSER CURVATURE OF STOMACH, THE DEVICE WAS USED IN AN ATTEMPT TO CONTROL THE BLEEDING. AT THAT MOMENT, THE HEAVY BLEEDING OCCURRED. THE SURGEON TRIED TO STOP THE BLEEDING BY GAUZE, BUT COULDN'T. THE PT'S PRESSURE WAS GOING DOWN. THEREFORE, IT CONVERTED TO OPEN PROCEDURE. ON THE SAME DAY, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA E4K55R

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death GENERATOR| HANDPIECE