BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1063354 · Received June 19, 2008

    Report

    Report Number
    1219930-2008-00470
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 5, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 06/19/08.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: AFTER THE DEVICE WAS FIRED THE DONUTS WERE GOOD. UPON DOING BUBBLE TEST A LEAK WAS NOTICED. THE SURGEON OVER SEW THE STAPLE LINE TO CORRECT THE LEAK. NO TISSUE LOSS AND NO BLEEDING OCCURRED AS A RESULT, HOWEVER, SURGERY TIME WAS EXTENDED BY FORTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8A132H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention