BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN

    MDR report key: 5343599 · Received December 22, 2015

    Report

    Report Number
    5343599
    Event Type
    Death
    Date Received
    December 22, 2015
    Date of Event
    December 9, 2015
    Report Date
    December 17, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    DURING EXTENDED RIGHT HEPATECTOMY TO TREAT A HILAR CHOLANGIOCARCINOMA, THE BASE OF THE MIDDLE HEPATIC VEIN WAS LIGATED USING AN ENDO GIA UNIVERSAL VASCULAR LOAD STAPLER. THE STAPLING DEVICE WAS APPLIED IN THE STANDARD FASHION. AFTER FIRING THE STAPLER AN OPENING WAS NOTED IN THE VENA CAVA WHERE THE BASE OF THE MIDDLE HEPATIC VEIN HAD BEEN. THE CAUSE WAS LIKELY EITHER THE STAPLER MISFIRING OR THE STAPLE FIRING CORRECTLY BUT THE ACT OF STAPLING CAUSING THE BASE OF THE MIDDLE HEPATIC VEIN TO AVULSE FROM ITS ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846656 COVIDIEN ENDO CIA ULTRA UNIVERSAL STAPLER HAN GDW MEDTRONIC P5G0337X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death