BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL XL

    MDR report key: 3894119 · Received June 20, 2014

    Report

    Report Number
    1219930-2014-00461
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT DURING SURGERY, FEW STAPLES DID NOT SHUT DOWN PROPERLY; THEREFORE, DID NOT HOLD THE SUTURE WHICH LEAD TO A FISTULA. THE SURGEON HAD TO RE-OPERATE THE PT THE NEXT DAY AND THE PT HAD TO HAVE A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364231 ENDO GIA UNIVERSAL XL DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY US SURGICAL N3K1778X

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPIRATION DATE: 10/31/2018, K900129| LOT #N3K1387LX, MANUFACTURE DATE: 10/2013,| ENDO GIA ROTICULATOR 45-3.5, 030455,