BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 10572986 · Received September 23, 2020

    Report

    Report Number
    10572986
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 16, 2020
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN LP ENDO GIA (B)(4) ARTICULATING RELOAD WITH TRI-STAPLE TECHNOLOGY FAILED TO OPEN AFTER INSERTING 60MM RELOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038624 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP EGIA60AVM POC1440KY

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA