BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET TRS

    MDR report key: 2112249 · Received May 30, 2011

    Report

    Report Number
    2112249
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 30, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A SLEEVE GASTRECTOMY, SURGEON WAS ATTEMPTING TO RESECT/STAPLE A PORTION OF THE FUNDUS WHEN THE STAPLER LOAD FAILED TO DEPLOY COMPLETELY. THE FAULTY, PARTIALLY FIRED LOAD WAS REMOVED FROM THE SURGICAL FIELD AND SEQUESTERED FOR BIO-MED ANALYSIS. THE FAULTY LOAD WAS REPLACED AND THE PROCEDURE WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET TRS STAPLER, RELOAD, SURGICAL GDW COVIDIEN DUET6048A *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR