BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN ENDO GIA STAPLER

    MDR report key: 2517568 · Received March 29, 2012

    Report

    Report Number
    MW5024863
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 29, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN ENDO GIA STAPLER RELOAD 45 BLUE ROTICULATING R# 030455 PARTIALLY FIRED/BENT ON LESSER CURVE OF STOMACH. SOME STAPLES FORMED AND SOME DID NOT. ADD'L STAPLE RELOADS HAD TO BE OPENED AND THE TISSUE HAD TO BE OVER SEWN BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN ENDO GIA STAPLER STAPLER GDW COVIDIEN N1M0067LX

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability