BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1052815 · Received May 27, 2008

    Report

    Report Number
    1219930-2008-00403
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 28, 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: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE PT EXPERIENCED A POST OPERATIVE LEAK AT THE ANASTOMOSIS. THE CT SCAN SHOWED FREE AIR AND A SMALL AMOUNT OF FLUID AROUND THE ANASTOMOSIS. THE PT HAS NOT BEEN RE-OPERATED AS PHYSICIAN IS TRYING TO TREAT THE CONDITION WITH MEDICINE. NOTHING ABNORMAL WAS NOTED DURING THE APPLICATION OF THE DEVICE AND THE DONUTS WERE COMPLETE AND NORMAL. NO STAPLE REINFORCEMENT MATERIAL USED DURING THE PROCEDURE. THE ANASTOMOSIS WAS CHECKED FOR LEAKS DURING THE PROCEDURE BUT NONE WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8C32H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R