BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 584294 · Received March 16, 2005

    Report

    Report Number
    MW1034941
    Event Type
    Injury
    Date Received
    March 16, 2005
    Date of Event
    March 10, 2005
    Report Date
    March 16, 2005
    Manufacturer
    ETHICON
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INTERNAL STAPLER MALFUNCTIONED AND COULD NOT BE DISLODGED FROM THE VESSEL. THE SECOND STAPLER WAS PUT IN IN AN ATTEMPT TO LIGATE THE VESSEL, BUT THE POSITIONING WAS NOT CONDUCIVE TO FIRING. THE RENAL ARTERY WAS TORN, RESULTING IN THE NEED TO CONVERT TO AN OPEN PROCEDURE. CELL SAVER AND BLOOD PRODUCTS WERE NEEDED. STAPLER WAS FOUND TO NOT FUNCTION CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. INTERNAL STAPLER KOG ETHICON ETS-FLEX-ENDOSCOPIC P30170P14

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening