BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL XL STAPLER

    MDR report key: 1820686 · Received August 27, 2010

    Report

    Report Number
    1219930-2010-00675
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SURGEON CREATED A GASTRIC POUCH FIRST, USING (B)(4) AND ONE (B)(4) TO COMPLETE THE POUCH. THE STAPLE LINES BLED AND REQUIRED CAUTERY AND/OR OVERSEWING. WHEN THE SURGEON PERFORMED A LEAK TEST, THERE WAS BUBBLING FROM THE 2ND AND 3RD POUCH STAPLE LINES. THIS WAS NOT FROM THE ANASTOMOSIS, BUT FROM THE POUCH STAPLE LINE. ALL STAPLES FORMED WELL DURING FIRING. THE PT EXPERIENCED SOME UNMEASURABLE BLOOD LOSS POST-OPERATIVELY BUT DID NOT REQUIRE TRANSFUSION. THE SURGEON PLACED A J TUBE FOR DRAINAGE, SENT THE PT TO ICU OVERNIGHT, AND PERFORMED ADD'L TESTING DAY 1 POST OPERATIVELY. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. PT STATUS WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL XL STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0D0442UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O MFR DATE: 5/2010| (B)(4) ARTICULATING VAS/MED SULU| (B)(4), LOT #: N0E0418U, EXP DATE: 5/31/2015