BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 2895358 · Received October 26, 2012

    Report

    Report Number
    1219930-2012-00862
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 9, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHEN USING THE DEVICE, THE TISSUE WAS JAMMING THE UNIT. IT WAS NOTICED THAT THE DEVICE DID NOT WORK PROPERLY. THE DOCTOR REMOVED THE DEVICE AND HAD TO OVER SEW TO CORRECT THE AREA. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. FURTHER DETAILS RECEIVED VIA MEDWATCH FORM: WHEN USING THE ENDO GIA WITH TRI-STAPLE 45MM 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 EGIA 45 ARTICULATING MED/THICK SULU DISPOSABLE STAPLING DEVICE GDW COVIDIEN, FORMERLY US N2E0368ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other