BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1062617 · Received June 18, 2008

    Report

    Report Number
    1219930-2008-00463
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 12, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: CYSTECTOMY. ACCORDING TO THE REPORTER: WHEN ATTEMPTING TO FIRE THE STAPLE LOAD ON THE ANVIL PUSHED OUT OF THE STAPLER AND THE STAPLES DID NOT FIRE. INCOMPLETE STAPLING AND TRANSECTION RESULTED IN SIGNIFICANT BLEEDING. THIS WAS AN OPEN PROCEDURE SO VASCULAR CLAMPS WERE USED TO STOP THE BLEEDING. BLOOD LOSS DUE TO THE REPORTED INCIDENT WAS NOT KNOWN. TOTAL BLOOD LOSS FOR THE PROCEDURE WAS REPORTED AS 800CC. OR TIMEAS EXTENDED BY 15 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 030425