BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 1192771 · Received October 8, 2008

    Report

    Report Number
    1219930-2008-00738
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE SURGEON SCOPES AND WATER TESTS EACH ANASTOMOSIS, BUT THE PT DEVELOPED AN ANASTOMOTIC LEAK A FEW DAYS POST-OPERATIVELY. THE SURGEON DID AN END-TO-SIDE ANASTOMOSIS FOR DIVERTICULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R