BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 90 - 4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 4102917 · Received September 19, 2014

    Report

    Report Number
    2647580-2014-00780
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 4, 2014
    Report Date
    September 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE STAPLER DID NOT FIRE PROPERLY. USED ANOTHER DEVICE WITHOUT FURTHER CONSEQUENCE. TA90 4.8 STAPLER WAS FIRED ACROSS STOMACH DURING A GASTRECTOMY. STAPLER WAS CLOSED SUCCESSFULLY AND FIRED. HANDLE LOCKED OUT AND TISSUE WAS TRANSECTED. WHEN STAPLER WAS OPENED THE STAPLES HAD NOT FORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583591 TA 90 - 4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC TA9048S P3L0230X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other