BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 3800195 · Received April 28, 2014

    Report

    Report Number
    2647580-2014-00316
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 8, 2014
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGECTOMY. ACCORDING TO THE REPORTER: ON POSTOPERATIVE DAY 7 A LEAK WAS DISCOVERED. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND CORRECTED WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253963 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R