BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1780777 · Received July 27, 2010

    Report

    Report Number
    2647580-2010-00655
    Event Type
    Injury
    Date Received
    July 27, 2010
    Report Date
    July 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DEVICE WAS APPLIED TO THE BASE OF THE APPENDIX AND WAS CLAMPED DOWN AND THEN TIME WAS ALLOTTED FOR EXSANGUINATION. THE DEVICE WAS UNCLAMPED AND THE VESSEL BEGAN TO PROFUSELY BLEED. BLOOD LOSS WAS APPROX 250 CC. THE VESSEL NEEDED TO BE LOCATED AND CLIPPED WITH A VESSEL CLIP. BLOOD LOSS OPERATIVE TIME WAS EXTENDED APPROX 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE DISPOSABLE STAPLER GDW USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other