BEUDAMED
    FDA Adverse Event Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1121444 · Received August 13, 2008

    Report

    Report Number
    1219930-2008-00612
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE ORVIL ANVIL DISENGAGED FROM THE TUBE WHILE IN THE CAVITY. THE ORVIL WAS SAFELY TAKEN OUT USING A CLAMP AND THE PROCEDURE WAS COMPLETED USING A LINEAR STAPLER TO DO A SIDE TO SIDE ANASTOMOSIS. SURGERY TIME WAS EXTENDED ABOUT ONE HOUR AS A RESULT. NO PT INJURY, NO TISSUE LOSS OR DAMAGE, AND NO BLEEDING WAS REPORTED. THE PT IS IN WELL CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8A28

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention