BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3021634 · Received March 15, 2013

    Report

    Report Number
    2647580-2013-00152
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC P
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP SIGMOID. ACCORDING TO THE REPORTER: TWO 31 EEA STAPLERS WERE USED FOR THIS CASE. THE SURGEON ATTEMPTED TO COMPLETE THE PROCEDURE COMPLETELY LAPAROSCOPY BUT COULD NOT DUE TO DIFFICULTY IN PLACING THE STAPLER IN THE RIGHT SPOT. PERFORMED THE ANASTOMOSIS IN THE OPEN MANNER. THE FIRST ANASTOMOSIS, THE LEFT LATERAL ASPECT OF THE ANASTOMOSIS ALTHOUGH STAPLED, WAS OPEN TO GENTLE AIR PRESSURE VIA THE RECTUM. WE ATTEMPTED TO REPAIR THIS BUT ELECTED, SINCE WE HAD THE EXTRA TISSUE, TO TAKE DOWN THE ANASTOMOSIS ATTEMPT AND DO IT AGAIN. WE USED A BRAND NEW STAPLER 31 SIZE AGAIN AND THIS TIME, AGAIN WITH FULL DONUTS WE HAD AIR LEAKING FROM THE ENTIRE ANTERIOR ASPECT OF THE STAPLER SITE. WE REINFORCED THIS AND COVERED THE ANASTOMOSIS WITH OMENTUM. THE PT SO FAR HAS DONE WELL. IN THE FIRST ANASTOMOSIS, DIFFICULTY IN HAVING THE HEAD OF THE STAPLER TILT AND SINCE WE WERE LAPAROSCOPIC, I COULD NOT MANUALLY ASSIST THE STAPLER FROM BEING REMOVED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. REINFORCEMENT MATERIAL WAS NOT USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110421 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P

    Patients

    Seq Age Sex Outcome Treatment
    1