BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1083294 · Received July 28, 2008

    Report

    Report Number
    2647580-2008-00431
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: OPEN ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE SPACE WAS TIGHT AND VISIBILITY WAS POOR, AND WHEN THE DEVICE WAS FIRED, THE STAPLES WERE NOT PLACED. THE RECTUM HAD TO BE OVERSEWN AND A COLOSTOMY WAS PERFORMED. THE RECTUM WAS SUTURED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 60-4.8 SINGLE USE RELOADABLE STAPLER SURGICAL STAPLING DEVICE GDW PONCE - USS P7H884

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention