BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3131378 · Received May 13, 2013

    Report

    Report Number
    2647580-2013-00256
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 19, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: AFTER STAPLING AND CLOSING THE ANASTOMOSIS SOME LEAKING OCCURRED. THE SURGEON CLIPPED THE AREA OF THE LEAK BUT TWO DAYS LATER THE PT WAS BROUGHT BACK TO THE OPERATING ROOM WITH THE ENTIRE STAPLE LINE LEAKING. THE SURGEON HAD TO OVERSEW THE ENTIRE STAPLE LINE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO TISSUE DAMAGE REPORTED. A DELAY OF MORE THAN 30 MINUTES OCCURRED WHEN THE PT WAS BROUGHT BACK TO THE OPERATING ROOM FOR OVERSEWING. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212143 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2J0830X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other