BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 6152191 · Received December 7, 2016

    Report

    Report Number
    1219930-2016-01301
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR A SECOND DEVICE USED IN THE SAME CASE. USER FACILITY LISTED IN INITIAL REPORTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE. AFTER COMPLETION OF THIRD FIRING FOR THE SIDE-TO-SIDE ANASTOMOSIS WITH THE POWERED HANDLE, THE RELOAD GOT STUCK IN THE INTESTINAL TRACT AND COULD NOT BE REMOVED. THE SURGEON INVERTED THE INTESTINAL TRACT AND CONFIRMED THE STATUS. THE STAPLES AT A DISTANCE OF ONE CENTIMETER FROM THE PROXIMAL END OF THE RELOAD REMAINED IN THE STAPLE POCKET. THEY GOT STUCK WITH THE TISSUE. USING TWEEZERS, THE SURGEON REMOVED THE STAPLES FROM THE TISSUE. OOZING AND BLEEDING WAS FOUND WHERE THE STAPLES GOT ENTANGLED. THE SURGEON DECIDED TO RESECT THE ANASTOMOSIS PART AND PERFORM THE FEEA AGAIN WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES DUE TO THE ISSUE. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE AND CAUSED TISSUE DAMAGE. THE LAST KNOWN STATUS OF THE PATIENT IS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802230 EGIA 60 ARTICULATING MED/THICK SULU STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AMT N6H0761KX

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention