BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES* EEA* ORVIL* 25 MM DEVICE

    MDR report key: 3876257 · Received June 4, 2014

    Report

    Report Number
    1219930-2014-00424
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K093402
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: AS THE ORVIL ANVIL WAS ATTEMPTED TO BE CONNECTED TO THE TROCAR OF EEAXL2535, THE TWO WOULD NOT PROPERLY MATE TO MAKE THE AUDIBLE CLICKING SOUND. UPON INITIAL INSPECTION, IT LOOKED LIKE ONE OF THE CONNECTION PRONGS ON THE ORVIL HAD BENT OUTWARD WHICH MAY HAVE PREVENTED PROPER MATING OF THE ANVIL TO THE STAPLER. THIS PROBLEM COULD NOT BE RESOLVED LAPAROSCOPICALLY SO PROCEDURE WAS CONVERTED TO OPEN. AFTER THE SURGEON USED A GRASPER TO PLACE THE METAL PRONG OF THE CONNECTING PORTION OF THE ANVIL BACK INTO PLACE, IT DID MAKE AN AUDIBLE CLICKING SOUND UPON CONNECTION. HOWEVER, THE ANVIL THEN STILL POPPED OFF UPON CLOSING THE EEA. THERE WAS A DELAY OVER 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326989 DST SERIES* EEA* ORVIL* 25 MM DEVICE DISPOSABLE SURGICAL STAPLER GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2A0184UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other