BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 1060323 · Received June 13, 2008

    Report

    Report Number
    1219930-2008-00454
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 06/13/2008.

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: PRODUCT BROKE APART DURING CASE AND CREATED A GASTRONOMY AT THE DISTAL HALF. THE STAPLE CARTRIDGE CUT A WHOLE IN THE STOMACH AND DID NOT STAPLE. X-RAY WAS PERFORMED TO MAKE SURE NO EXTRA PARTS WERE IN THE BODY. THE DOCTOR THEN USING A DIFFERENT DEVICE, STAPLED AND OVERSEWED TO REPAIR THE AREA. NO REPORTED BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-3.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention