BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM PLUS CEE 28

    MDR report key: 1564207 · Received November 9, 2009

    Report

    Report Number
    1564207
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    October 13, 2009
    Report Date
    November 9, 2009
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A LARGE LEAK NOTED IN THE ANASTOMOSIS. THE EEA STAPLER WAS FIRED IN THE STANDARD FASHION. THE ENTIRE PELVIS WAS THEN FILLED WITH SALINE, AND AT THIS POINT OF TIME, INSUFFLATIONS OF THE RECTUM WERE CARRIED OUT WHICH REVEALED A DEFECT APPROXIMATELY 1.5 CENTIMETERS IN THE ANTERIOR WALL OF THE RECTUM. POSSIBLY DUE TO THE STAPLER MISFIRE. WE COULD NOT EXACTLY FIGURE OUT WHY IT HAPPENED, AS THE DOUGHNUT ITSELF APPEARED TO BE COMPLETELY STABLE AND COMPLETE. THE STAPLER ITSELF WAS THEN FORWARDED TO BIOMED. IN VIEW OF THE FACT THAT THE REST OF THE MUCOSAL VIABILITY WAS INTACT AND IN VIEW OF THE FACT THE DEFECT APPEARED TO BE LOCALIZED TO ONE AREA AND IN THE ANTERIOR PART, WE ELECTED TO CLOSE THE DEFECT USING INTERRUPTED SUTURE WITH AN INNER LAYER OF 2-0 PROLENE AND THE OUTER LAYER OF SEROMUSCULAR WITH 3-0 SILK SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEE 28 STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * P8L0639J

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR