BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 4753699 · Received May 6, 2015

    Report

    Report Number
    2647580-2015-00316
    Event Type
    Injury
    Date Received
    May 6, 2015
    Report Date
    April 28, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON 05/06/2015.

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE ANVIL BECAME DISENGAGED AND LODGED IN THE PATIENT'S ESOPHAGUS. THE PHYSICIAN WAS ABLE TO RETRIEVE THE ANVIL USING A SCOPE. THEY HAD TO OPEN THE PATIENT TO GET THE ANVIL OUT. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO BLOOD LOSS OVER 500CC. THERE WAS A DELAY IN SURGICAL TIME GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297774 EEA 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA25

    Patients

    Seq Age Sex Outcome Treatment
    1 Other