BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DST SERIES

    MDR report key: 2250836 · Received September 2, 2011

    Report

    Report Number
    2250836
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING THE ANVIL INTO THE STOMACH, THE WHITE TIP WITH ATTACHED SUTURE BECAME DISLODGED FROM THE ANVIL OF THE EEA. THE TIP WAS REMOVED. THE ANVIL WAS LOCATED IN THE STOMACH AND REMOVED. UPON REMOVAL, THE ANVIL WAS BENT AND WOULD NOT WORK WITH THE STAPLER, THEREFORE, IT WAS REMOVED AND ANOTHER EEA STAPLER WAS THROWN TO THE STERILE FIELD. THE PROCEDURE THEN CONTINUED NORMALLY AFTER THIS WAS RESOLVED.======================MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, DST SERIES (PER SITE REPORTER): THEY WILL PICK UP THE DEVICE TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES STAPLER, SURGICAL GDW COVIDIEN EEAXL2535 POJ0419H

    Patients

    Seq Age Sex Outcome Treatment
    1 *