BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO LINEAR CUTTERS - ETS45MM

    MDR report key: 495603 · Received November 14, 2003

    Report

    Report Number
    1527736-2003-02372
    Event Type
    Death
    Date Received
    November 14, 2003
    Date of Event
    October 15, 2003
    Report Date
    October 20, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PARTIAL HEPATECTOMY, THE ORIGINAL CARTRIDGE WAS USED SUCCESSFULLY, BUT WHEN THE RELOAD WAS FIRED, THE CUT LINE WAS APPARENT BUT NO STAPLE LINE WAS PRESENT. THIS CAUSED A HOLE IN THE INFERIOR VENA CAVA WHICH REQUIRED THE CARDIAC TEAM TO OPEN THE CHEST IN ORDER TO REPAIR. THE ANESTHESIOLOGIST WORKED FOR FOUR HOURS TO STABILIZE THE PATIENT. THE OR TIME WAS EXTENDED BY 4-6 HOURS, AND THE PATIENT LOST 600 ML OF BLOOD. THE PATIENT RECEIVED A TRANSFUSION OF SIX UNITS OF BLOOD. FOLLOWING A STAY IN THE INTENSIVE CARE UNIT, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO LINEAR CUTTERS - ETS45MM ENDO LINEAR CUTTERS - ETS45MM KOG ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death