BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL XL

    MDR report key: 1002007 · Received February 22, 2008

    Report

    Report Number
    1219930-2008-00173
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 30, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: UPON INSERTING STAPLER THROUGH SLEEVE TRYING TO LINE UP WITH THE BOWEL, THE JAWS DID NOT OPEN ALL THE WAY. FINALLY THE USER WAS ABLE TO GET THE STAPLER TO OPEN, POSITIONED BOWEL AND STAPLER AND STAPLED. STAPLES WERE NOT CLOSED OR FORMED. THEY OPENED A NEW STAPLER AND HAD TO RE-DO THE STAPLE LINE AND RESECT SOME OF THE STOMACH. IT WAS NOT KNOWN IF OR TIME WAS EXTENDED OR ABNORMAL BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL XL DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS N7L418

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention PRODUCT ID #: 030455| ENDO GIA ROTICULATOR 45-3.5 SULU