BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA* II 45-3.5 DLU

    MDR report key: 3904218 · Received June 2, 2014

    Report

    Report Number
    2647580-2014-00405
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THERE WAS POSTOPERATIVE BLEEDING. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. NO REOPERATION WAS NEEDED. NO TRANSFUSION WAS NEEDED. NO REINFORCEMENT MATERIAL USED. THERE WAS EXTENDED HOSPITAL STAY. SUBSEQUENT FOLLOW UP: FOLLOWING SURGERY HOW WAS THE BLEEDING RECOGNIZED: BLOOD IN FECES, MELENA SYMPTOMS, DECREASED HGB. WERE THERE ANY PROBLEMS WITH BLEEDING NOTED AT THE TIME OF THE ORIGINAL SURGERY: THE SURGEONS HAS BEEN PLACING MORE CLIPS ON THE STAPLE ROW THAT THEY USE TO DO AND FEELS THAT IS BLEEDING MORE FROM THE RELOADS. WHERE WAS THE BLEEDING NOTED TO BE COMING FROM: (GASTROJEJUNOSTOMY (LINEAR FORMED OR CIRCULAR FORMED?) JEJUJEUNOSTOMY: IN ALL CASES BLEEDING CAME FROM GASTROJEJUJUNOSTOMY MADE WITH RELOAD 030422. WHAT WAS DONE TO CONTROL THE BLEEDING OR HOW WAS THE BLEEDING TREATED: BY SEWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322221 ENDO GIA* II 45-3.5 DLU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R EGIA ULTRA UNIVERSAL XL STAPLER, EGIAUXL, K083519