BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1130463 · Received August 20, 2008

    Report

    Report Number
    1219930-2008-00623
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 8/20/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE ORVIL WAS INSERTED DOWN THE ESOPHAGUS BUT THE ENTIRE ANVIL PULLED THROUGH THE GASTROSTOMY AFTER THE SURGEON CLIPPED THE SUTURE TO DETACH THE ANVIL FROM THE TUBE. A SECOND ORVIL WAS INSERTED AND IT DETACHED FROM THE TUBE AS IT WAS DESCENDING DOWN THE ESOPHAGUS. THE ORVIL ANVIL WAS REMOVED WITH A SNARE. A THIRD ORVIL WORKED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO TISSUE LOSS OR DAMAGE, AND NO ADD'L BLOOD LOSS. THE SURGICAL TIME WAS EXTENDED BY 35 MINUTES AS A RESULT. 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 U8F55

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention