BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DST SERIES, EEA

    MDR report key: 1990057 · Received February 9, 2011

    Report

    Report Number
    1990057
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A ROUX-EN-Y GASTRIC BYPASS. THE STAPLER USED FOR AN ANASTOMOSIS MISFIRED. THE ANASTOMOSIS LEAKED WHEN TESTED WITH METHYLENE BLUE. A SECOND STAPLER AND EXTRA RELOADS WERE OPENED AND USED TO REPAIR THE ANASTOMOSIS. THE SECOND ANASTOMOSIS SHOWED NO SIGNS OF LEAKAGE. THE PATIENT HAD NO NEGATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES, EEA STAPLER, SURGICAL GDW COVIDIEN EEA21 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR