BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 21 MM SINGLE-USE STAPLER

    MDR report key: 3170444 · Received June 10, 2013

    Report

    Report Number
    2647580-2013-00316
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE EEAXL21 WAS USED WITH THE ORVIL DEVICE AND SEEMED TO HAVE PUNCTURED THROUGH THE ANASTOMOSIS AFTER THE TWO DEVICES WERE CONNECTED AND FIRED. THE SURGEON STAPLED THE DAMAGED ANASTOMOSIS SHUT AND USED A EEAORVIL25 AND EEAXL25 TO CREATE A NEW ANASTOMOSIS. EVERYTHING WORKED OUT WELL THE SECOND TIME AND NO COMPLICATIONS FROM THIS DELAY OCCURRED. POST-OP DIAGNOSIS: NO COMPLICATIONS, STANDARD LENGTH OF STAY FOR PROCEDURE. ANOTHER MFR'S REINFORCEMENT MATERIAL WAS USED. NO OTHER MFRS' PRODUCTS WERE USED WITH THIS DEVICE. UNANTICIPATED TISSUE LOSS DID OCCUR, A NEW ANASTOMOSIS WAS PERFORMED AND CLOSED THE PREVIOUS ONE WITH ANOTHER EEA STAPLER. NO UNANTICIPATED EXTENSION OF THE INCISION BY MORE THAN ONE INCH, NO UNANTICIPATED BLOOD LOSS OF 500 CC OR MORE. SURGICAL TIME WAS DELAYED BY MORE THAN 30 MINUTES, THE DELAY DID NOT AFFECT THE PATIENT IN ANY WAY. DEVICE FRAGMENT OR COMPONENT DID NOT FALL INTO THE PATIENT'S CAVITY, NO DEVICE FRAGMENT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261496 EEA XL 21 MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN P2K0684X

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R EEA ORVIL 21MM, ITEM EEAORVIL21,| LOT NUMBER UNK, K062850