BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1062615 · Received June 18, 2008

    Report

    Report Number
    1219930-2008-00464
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 8, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 06/18/2006.

    Description of Event or Problem · 1

    PROCEDURE: VATS LEFT UPPER LOBE. ACCORDING TO THE REPORTER: BEFORE FIRING, THE SURGEON CONFIRMED THAT THE JAWS WOULD FULLY CLOSE OVER THE TISSUE. HOWEVER, ONCE FIRED, STAPLES DID NOT FORM PROPERLY AND OOZING BLEEDING OCCURRED. ANOTHER LOADING UNIT WAS APPLIED WITH ADDITIONAL TISSUE LOSS. SURGERY TIME EXTENSION WAS REPORTED AS BETWEEN 30 AND 60 MINS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT NUMBER N8B87| 030458| MANUFACTURE DATE 02/2008.