BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 1482561 · Received September 21, 2009

    Report

    Report Number
    1219930-2009-00626
    Event Type
    Injury
    Date Received
    September 21, 2009
    Date of Event
    July 20, 2009
    Report Date
    August 24, 2009
    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

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 9/18/2009.

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORT: THE STAPLING WAS INCOMPLETE WITH MISTAPLING ON ONE QUARTER OF THE ANASTOMOSIS. THIS REQUIRED SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8H67H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention