BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA* UNIVERSAL

    MDR report key: 1082203 · Received July 25, 2008

    Report

    Report Number
    1219930-2008-00559
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: THE STAPLE LINE CAME OFF THE RENAL ARTERY. THE STAPLE LINE WAS OVER SEWED. DELAY IN SURGERY TIME WAS REPORTED AS 60 MINUTES. TISSUE DAMAGE WAS REPORTED. BLOOD LOSS WAS REPORTED WITH NO AMOUNT GIVEN. A VASCULAR SURGEON AND REPAIRED THE DIAPHRAM AND VASCULAR STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA* UNIVERSAL DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8C482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention