BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN

    MDR report key: 3467611 · Received November 6, 2013

    Report

    Report Number
    3467611
    Event Type
    Death
    Date Received
    November 6, 2013
    Date of Event
    October 30, 2013
    Report Date
    November 5, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE WITH ENLARGING LIVER HEMANGIOMA UNDERWENT HAND-ASSISTED LAPAROSCOPIC MOBILIZATION OF RIGHT LIVER; INTRAOPERATIVE ULTRASOUND; ATTENTION AT HEPATIC RESECTION; CONVERSION TO OPEN PROCEDURE; MEDIAN STERNOTOMY; PLACEMENT OF EXTRACORPOREAL CIRCUIT. FROM OPERATIVE DICTATION, AFTER FIRING A VASCULAR STAPLER ACROSS THE RIGHT HEPATIC VEIN, BLEEDING FROM THE VENA CAVA OCCURRED WHICH COULD NOT BE CONTROLLED. IT IS UNCLEAR IF THE STAPLES DID NOT SEAT WELL OR THE STAPLER MISFIRED, BUT A VENOTOMY WAS NOTED. MASSIVE EXSANGUINATION AND INTRAOPERATIVE DEATH DESPITE AGGRESSIVE MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572241 COVIDIEN ENDO GIA STAPLER AND STAPLE CARTRIDGE GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death