BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1241003 · Received November 21, 2008

    Report

    Report Number
    1219930-2008-00851
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 7, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE SURGEON HAD DIFFICULTY WHEN LOADING THE INSTRUMENT AND THE JAWS WOULD NOT CLOSE. HOWEVER, THE GREEN BUTTON WAS ABLE TO BE PRESSED SO THE INSTRUMENT WAS FIRED AS USUAL. HOWEVER, ONLY ONE THIRD OF THE STAPLES WERE FORMED ON TISSUE PROPERLY. THIS PROBLEM OCCURRED THREE TIMES IN A ROW AFTER FIFTH FIRING. NEW CARTRIDGES WERE FIRED OVER THE PREVIOUS STAPLE LINES WITHOUT ADDITIONAL TISSUE LOSS. EXTENDED OR TIME WAS REPORTED AS APPROXIMATELY 30 MINUTES. THE SULUS WERE ALL DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 030455