BEUDAMED
    FDA Adverse Event Death Summary report: N

    DST SERIES TA

    MDR report key: 3940322 · Received July 14, 2014

    Report

    Report Number
    3940322
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 11, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TWO ROWS OF THREE LINES OF STAPLES WERE PLACED IN VEIN TO ENABLE LIVER RESECTION. DURING PROCEDURE, A LARGE BLEED OCCURRED FILLING THE PATIENT'S ABDOMEN. AS SOON AS THE BLOOD WAS SUCKED OUT, THE VEIN WAS EXPOSED AND AIR WAS SUCKED INTO THE VEIN DUE TO INCOMPLETE CLOSURE FROM STAPLES. PATIENT DIED FROM AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410062 DST SERIES TA STAPLE, IMPLANTABLE GDW COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death