BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1770183 · Received July 20, 2010

    Report

    Report Number
    1219930-2010-00561
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 16, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, THE DEVICE WAS USED WITH TWO LOADING UNITS. WHEN THE SURGEON TRIED TO INSERT THE EEA31 TO THE RECTAL STUMP, THE STAPLE LINE (FROM THE ENDO GIA) WAS DISCOVER TO BE INSECURE. THE SURGEON NEEDED TO USE SUTURE TO SECURE THE STAPLE LINE TO CONTINUE THE SURGERY. THERE WAS NO ADDITIONAL BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES AND THE STAPLE LINE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N9M0230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other