BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1747729 · Received June 29, 2010

    Report

    Report Number
    1219930-2010-00476
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    May 18, 2010
    Report Date
    June 11, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC ASSISTED RIGHT HEPATECTOMY. ACCORDING TO THE REPORTER: THE CUSTOMER WAS USING THE ENDO GIA TO TRANSECT PARENCHYMA AND WHEN CONVENIENT, USED STAPLER TO DIVIDE RIGHT HEPATIC VEIN. THE RIGHT HEPATIC VEIN STAPLE LINE SEEMED TO FAIL 20 MINUTES LATER. WHEN ETH LIVER WAS LIFTED TO VISUALIZE, A 6CM TEAR ORIGINATING FROM THE STAPLE LINE WAS SEEN. BLOOD WAS HEMORRHAGING AND THE SURGERY WAS CONVERTED TO AN OPEN PROCEDURE. FURTHER ATTEMPTS TO CONTROL THE BLEEDING FAILED, AND THE PT PASSED AWAY DURING SURGERY. ALTHOUGH THE SURGEON FEELS, IT WAS MOST LIKELY NOT STAPLE LINE FAILURE, HE IS UNSURE HOW IT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0A0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 030457| ENDO GIA ROTICULATOR 60-2.5 SULU