BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ARTICULATING RELOAD WITH TRI-STAPLE TECHNOLOGY

    MDR report key: 4173560 · Received September 19, 2014

    Report

    Report Number
    4173560
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 7, 2014
    Report Date
    September 19, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHEN LOADING THE EGIA60AXT, THE SILVER OUTER PORTION OF THE SHAFT WAS NOT SECURELY FASTENED TO THE INSTRUMENT CAUSING THE SCRUB TECH TO NOT BE ABLE TO LOAD THE STAPLER. AFTER INSPECTION OF THE STERILE FIELD, IT LOCKED INTO PLACE, BUT AT THAT POINT IT WAS TOO LATE AS IT WAS NOW NON STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582910 ENDO GIA ARTICULATING RELOAD WITH TRI-STAPLE TECHNOLOGY STAPLE, IMPLANTABLE GDW COVIDIEN LP 60MM EXTRA THICK N4B0399KX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NOT APPLICABLE.