BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3800314 · Received May 2, 2014

    Report

    Report Number
    2647580-2014-00330
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 11, 2014
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: RIGHT HEMICOLECTOMY. ACCORDING TO THE REPORTER: CUSTOMER REPORTS THAT THE SURGEON FIRED THE DEVICE, NOTICED MALFORMED STAPLES AND HAD TO OVERSEW THE STAPLE LINE. PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM HOURS LATER WITH SUSPECTED LEAK OF STAPLE LINE. NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING. NO EXTENSION TO SURGICAL TIME REQUIRED. NOTHING FELL IN THE SURGICAL CAVITY. THE DEVICE IS BEING RETURNED FOR EVALUATION. REINFORCEMENT MATERIAL WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263747 TA 60-3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P3J0589KX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other