BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTICULATOR 30-V3 TITANIUM STAPLER

    MDR report key: 2953806 · Received January 31, 2013

    Report

    Report Number
    2647580-2013-00055
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC P
    Product Code
    GDW
    PMA / PMN Number
    K855047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: PULMONARY VESSEL WAS SEVERED AND THE SURGEON HAD TO REPAIR IT TO SAFE PT FROM MASSIVE HEMORRHAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. REINFORCEMENT MATERIAL BEING USED IN CONJUNCTION WITH THE STAPLING DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42111 ROTICULATOR 30-V3 TITANIUM STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P P8C0825

    Patients

    Seq Age Sex Outcome Treatment
    1 Other