BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 3170126 · Received June 6, 2013

    Report

    Report Number
    2647580-2013-00322
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: THE HANDLE WOULD NOT MOVE DURING FIRING AND THE SURGEON FORCIBLY RETRACTED THE BLACK RETURN KNOB TO OPEN THE JAWS. THE PART WAS ADDITIONALLY EXCISED WITH A NEW CARTRIDGE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM. THERE WAS OOZING, TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS. NOTHING FELL INTO CAVITY, NO PT HARM. OPERATING TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES, NO INFORMATION ABOUT THE USE OF REINFORCEMENT MATERIAL WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252010 ENDO GIA II 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P2L0117X

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability