BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA

    MDR report key: 8315788 · Received February 7, 2019

    Report

    Report Number
    1219930-2019-00752
    Event Type
    Death
    Date Received
    February 7, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 7, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884521191010
    PMA / PMN Number
    K133938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT DIED ON THE 2ND DAY AFTER THE OPERATION. IT WAS REPORTED THE EVENT OCCURRED IN THE 1ST FIRING AND REINFORCE 60 PURPLE WAS USED IN THE RECTUM RESECTION. THE DEVICE WORKED NORMALLY AND THERE WAS NO PROBLEM WITH THE MALFORMATION. THE PATIENT HAD SLIGHT BLEEDING AND NO BLOOD TRANSFUSION. THERE WAS NO TISSUE DAMAGE. THE PATIENT HAD CARDIAC ARREST WITH ACUTE HEART FAILURE ON THE 2ND POSTOPERATIVE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107844 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIATRS60AMT 20884521191010

    Patients

    Seq Age Sex Outcome Treatment
    1 Death