BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE

    MDR report key: 512503 · Received February 12, 2004

    Report

    Report Number
    512503
    Event Type
    Death
    Date Received
    February 12, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 12, 2004
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LARGE BOWEL RESECTION AND UNDERWENT AN EXPLORATORY LAPAR-OTOMY W/HARTMAN'S PROCEDURE, SIGMOID RESECTION. THE COLON WAS GUNNED APROX. 12CM PROXIMAL TO A CANCEROUS TUMOR WITH A GIA ATA-90, WHICH MIS-FIRED. A SECOND TA-60 WAS USED AND IT ALSO MIS-FIRED. PATIENT REQUIRED VENTILATORY SUPPORT POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO GIA STAPLER KOG UNITED STATES SURGICAL TA 6035S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death