BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 3232237 · Received July 8, 2013

    Report

    Report Number
    2647580-2013-00378
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PROXIMAL PANCREATICODUODENECTOMY. ACCORDING TO THE REPORTER: AFTER THE FIRING, THE SURGEON FOUND THE STAPLES WERE MALFORMED. THE PT SIDE OF THE MALFORMED STAPLE LINE WAS ADDITIONALLY CUT WITH A NEW CARTRIDGE, THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM. THERE WAS NO INFO ABOUT THE USE OF REINFORCEMENT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310288 ENDO GIA II 60-3.5 SULU DISPOSABLE STAPLE DEVICE GDW COVIDIEN, FORMERLY USSC P2L0307X

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability