BEUDAMED
    FDA Adverse Event Other Summary report: N

    COVIDIEN

    MDR report key: 2763762 · Received September 21, 2012

    Report

    Report Number
    2763762
    Event Type
    Other
    Date Received
    September 21, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE ENDO GIA WITH TRI-STAPLE 45 MM PURPLE RELOAD THE STAPLER WAS USED AND TISSUE GOT CAUGHT IN THE STAPLER. THE SURGEON HAD TO REMOVE THE TISSUE AND OVER SEW THE STAPLE LINE. AFTER FIRING THE STAPLER, THE TISSUE DID NOT SEPARATE LIKE IT NORMALLY DOES. INSTEAD IT WAS CAUGHT IN THE STAPLER ITSELF. THE SURGEON REPAIRED THE TISSUE DAMAGE, NO FURTHER CONCERN FOR THAT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN ENDO GIA TRI-STAPLE GDW COVIDIEN N2E0368ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR