BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1221919 · Received November 4, 2008

    Report

    Report Number
    1219930-2008-00804
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE STAPLER APPEARED TO HAVE FIRED NORMALLY, BUT THERE WAS DIFFICULTY REMOVING AFTER IT HAD BEEN FIRED. SURGEON BELIEVED THE KNIFE DID NOT CUT THROUGH ALL THE TISSUE AND THE TISSUE WAS TORN DURING REMOVAL. THE DONUT WAS COMPLETE, BUT VERY THIN. A LEAK WAS SEEN DURING TESTING AND THE ANASTOMOSIS WAS REINFORCED WITH SUTURES AND TESTED AGAIN WITH BETADINE. ALSO, A RIGID SIGMOIDOSCOPY WAS TO BE PERFORMED TO CHECK THE ANASTOMOSIS. SURGERY TIME WAS EXTENDED THIRTY MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8G43H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention