BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-4.8 SULU

    MDR report key: 1233968 · Received November 14, 2008

    Report

    Report Number
    1219930-2008-00831
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 13, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: BULLECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT WOULD NOT CUT TISSUE AND STAPLED ONLY THE PROXIMAL END OF THE TISSUE. TISSUE WAS RESECTED WITH A NEW SULU TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-4.8 SULU DISPOSABLE STAPLER GDW NORTH HAVEN - USS N8C304

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability