BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7130404 · Received December 19, 2017

    Report

    Report Number
    1219930-2017-10190
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Report Date
    December 19, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    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: OCCURRED DURING AN UNKNOWN PROCEDURE. THE HANDLE JAMMED AFTER THE FIRST FIRING. HANDLE REFUSED TO FIRE/MOVE, ANY EXTRA FORCE WOULD HAVE CAUSED THE DEVICE TO BREAK. FIRING MOTION WAS NORMAL IN THE FIRST RELOAD USED, HOWEVER THE JAMMING HAPPENED IN THE SECOND RELOAD. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910690 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EGIA SU

    Patients

    Seq Age Sex Outcome Treatment
    1