BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ILS

    MDR report key: 449964 · Received March 14, 2003

    Report

    Report Number
    449964
    Event Type
    Death
    Date Received
    March 14, 2003
    Date of Event
    February 4, 2003
    Report Date
    March 12, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC, A JOHNSON AND JOHNSON CO
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT THREE DAYS POST-OP FOR A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS WITH A 120CM ANTECOLIC ROUX LIMB USING A 25MM STAPLER AND CHOLECYSTECTOMY. APPROX 7 HOURS AFTER DISCHARGE PT RETURNED T0 EMERGENCY DEPT WITH CHEST PRESSURE AND VOMITING. PT UNDERWENT AN EMERGENCY EXPLORATORY LAPAROTOMY AND EXPIRED THREE HOURS LATER. SURGEON SUSPECTS THAT 25MM STAPLER FAILED ALONG THE BOTTOM OF THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOPATH CONMED INTERNATIONAL STAPLER (25MM) KOG ETHICON ENDO-SURGERY, INC, A JOHNSON AND JOHNSON CO (REF) ECS25 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death