BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1081266 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00549
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: COLON RESECTION. ACCORDING TO THE REPORT: DURING A COLORECTAL ANASTOMOSIS PROCEDURE, THE UNIVERSAL GIA RELOAD STUCK AND MALFUNCTIONED. THE RELOAD HAD TO BE PREYED OPEN TO GET THE RELOAD OFF THE BOWEL. THIS RESULTED IN THE SURGEON HAVING TO RESECT TWO MORE PORTIONS OF SMALL BOWEL. REP CONTACTED AND SPOKE WITH SURGEON. DEVICE RETAINED AT HOSPITAL AND WILL BE RETURNED TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL DISPOSABLE STAPLER GDW NORTH HAVEN - USS N8B343

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability