BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2132233 · Received June 14, 2011

    Report

    Report Number
    1219930-2011-00495
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    June 3, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE DEVICE MISFIRED. THE STAPLER FIRED AND STAYED CLOSED ON THE TISSUE. THE ANVIL DID NOT RETURN TO THE PROXIMAL POSITION SO THEY COULDN'T OPEN THE STAPLER. THE SURGEON HAD TO FURTHER DISSECT THE INFERIOR PULMONARY VEIN AND CUT OFF ONE ROW OF THE STAPLES AND CLAMP ON EITHER SIDE OF THE VESSEL AND USE SUTURES TO TIE THE VESSEL. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N1C0294X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other