BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 3853502 · Received May 30, 2014

    Report

    Report Number
    2647580-2014-00397
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    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 INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318167 ENDO GIA II 45-3.5 DLU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC

    Patients

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