BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1060928 · Received June 13, 2008

    Report

    Report Number
    1219930-2008-00457
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 3, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP TOTAL GASTRECTOMY. ACCORDING TO THE RPTR: IT WAS HARD TO CONNECT ORVIL AND INSTRUMENT SHAFT. ONCE CONNECTED AND THE ANVIL STOOD STRAIGHT, THE CLOSED EDGE OF ESOPHAGUS WAS TORN AND THE INSTRUMENT WAS NOT FIRED. THE INCISION WAS EXTENDED FROM 7 CM TO 15 CM TO SUTURE THE TORN PART OF THE ESOPHAGUS AND A NEW INSTRUMENT OF DIFFERENT TYPE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING WAS REPORTED BUT SURGERY TIME WAS EXTENDED BY ONE HR AS A RESULT. THE PT IS IN WELL CURRENT CONDITION AND UNDER OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATALOG #: EEAXL25| EEA XL 25MM SINGLE-USE STAPLER| EXP DATE: 11/30/2012