BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1180105 · Received September 29, 2008

    Report

    Report Number
    1219930-2008-00707
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 09/29/2008.

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE JEJUNO-JEJUNOSTOMY WAS PERFORMED WITHOUT PROBLEMS. A SECOND PROCEDURE WAS PERFORMED TWO DAYS POST OP, DUE TO A STAPLE LINE LEAK. IT WAS NOTED DURING THE SECOND PROCEDURE THAT STAPLES WERE NOT FORMED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8E477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUFACTURE DATE 02/01/2008| LOT N8B80| EXPIRATION DATE: 02/28/2013| ENDO GIA ROTICULATOR 45-2.5 SULU