BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE

    MDR report key: 1012600 · Received March 12, 2008

    Report

    Report Number
    2647580-2008-00145
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 19, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE: APPENDECTOMY. ACCORDING TO THE REPORTER: AFTER DISSECTION OF THE APPENDIX, THE STAPLER WAS PLACED, CLOSED AND FIRED. THE INSTRUMENT CUT, BUT THERE WAS NO STAPLES IN THE MAGAZINE. BLEEDING OCCURRED AND THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE NONE GAG PONCE - USS P7G0402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention