BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO TA 30-2.5 12MM STAPLER

    MDR report key: 1241709 · Received November 19, 2008

    Report

    Report Number
    2647580-2008-00653
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K61095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 11/18/2008.

    Description of Event or Problem · 1

    PROCEDURE: LIVE DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT CLAMPED ONTO THE ARTERY AND VEIN. AFTER FIRING, THERE WAS SLIGHT BLEEDING. A CLIP WAS APPLIED OVER TO ENSURE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO TA 30-2.5 12MM STAPLER DISPOSABLE STAPLER GDW PONCE - USS P8J0125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention