BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA UNIVERSAL STAPLER

    MDR report key: 5885292 · Received August 18, 2016

    Report

    Report Number
    5885292
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Date of Event
    June 29, 2016
    Report Date
    August 8, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON STATES THAT LOAD WOULD BEGIN TO FIRE THEN STOP. A NEW HANDLE AND LOAD WAS USED TO COMPLETE PROCEDURE. MANUFACTURER RESPONSE FOR ENDO GIA ULTRA UNIVERSAL STAPLER, COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER (PER SITE REPORTER): MANUFACTURER PROVIDED RGA# AND RETURN PACKAGING. MANUFACTURER RESPONSE FOR STAPLE LOAD, ENDO GIA STAPLE LOAD (PER SITE REPORTER): MANUFACTURER PROVIDED RGA# AND PRODUCT RETURN PACKAGING. MANUFACTURER RESPONSE FOR STAPLE LOAD, ENDO GIA (PER SITE REPORTER): MANUFACTURER PROVIDED RGA# AND PRODUCT RETURN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537515 ENDO GIA ULTRA UNIVERSAL STAPLER STAPLER, SURGICAL GDW COVIDIEN EGIAUSHORT P6D0357X

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR