BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 31MM SINGLE-USE STAPLER

    MDR report key: 1033853 · Received April 24, 2008

    Report

    Report Number
    1219930-2008-00324
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 1, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DEVICE WAS APPLIED AND A LEAK TEST WAS PERFORMED WITH NO LEAK. THE PT WAS RETURNED TO THE OR TWO WEEKS LATER DUE TO ANASTOMOTIC LEAKAGE, AND A LAPAROTOMY WAS PERFORMED. A HOLE IN THE ANASTOMOSIS WAS DISCOVERED AT THE TIME. IT IS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THE PT IS REPORTED DOING WELL CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R