BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1163128 · Received September 16, 2008

    Report

    Report Number
    1219930-2008-00686
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: THE DEVICE CUT BUT NOT STAPLE PROPERLY. WHEN REMOVING THE DEVICE, SOME TISSUES FROM THE PATIENT'S RECTUM CAME OUT. THE ANASTOMOSIS WAS RESECTED AND A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO BLOOD LOSS OCCURRED BUT SURGERY TIME WAS EXTENDED APPROXIMATELY THIRTY MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7D58

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention