BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1905774 · Received November 17, 2010

    Report

    Report Number
    1219930-2010-00881
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 20, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE ORVIL WAS STUCK IN PATIENT'S ESOPHAGUS, AND THE SUTURES RELEASED WITHOUT MUCH FORCE BEING USED. THE GI SPECIALIST CAME IN AND DID AN INTRAOPERATIVE EGD AND RETRIEVED THE DISLODGED ORVIL AND THEN AN ORVIL 21MM WAS USED AND PASSED THROUGH WITHOUT PROBLEMS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. OPERATIVE TIME WAS DELAYED APPROXIMATELY THIRTY TO FORTY FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GDW UNITED STATES SURGICAL N0H0029UL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other