BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOSURGERY INC.

    MDR report key: 751631 · Received July 25, 2006

    Report

    Report Number
    MW1039858
    Event Type
    Injury
    Date Received
    July 25, 2006
    Date of Event
    May 4, 2006
    Report Date
    July 25, 2006
    Manufacturer
    ETHICON
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR WAS TRYING TO STAPLE OFF THE 8X30 FEMORAL CANNULATION GRAFT & THE DEVICE FAILED TO FIRE. GRAFT RECLAMPED & WAS HAND SEWN CLOSED. BECAUSE THE DEVICE FAILED TO FIRE THE GRAFT WAS ALLOWED TO OPEN & RESULTED IN A VERY SHORT BURST OF BLEEDING FROM THE FEMORAL ARTERY. NO APPARENT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSURGERY INC. * KOG ETHICON TX 30V A4CW4R

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Disability