BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1041153 · Received May 12, 2008

    Report

    Report Number
    1219930-2008-00372
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 18, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGECTOMY. PT: MALE, NOT OBESE. ACCORDING TO THE REPORTER: THE ANVIL WAS LODGED IN THE PT'S ESOPHAGUS. ONCE THE SURGEON TRIED TO REMOVE IT BY PULLING ON THE OG TUBE, THE ANVIL DISCONNECTED AND REMAINED IN THE ESOPHAGUS. A SCOPE AND A BALLOON DILATOR WAS USED TO REMOVE THE ANVIL. A SMALLER INSTRUMENT AND ANVIL WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO BLEEDING OCCURRED AND NO DAMAGE TO THE ESOPHAGUS WAS NOTED. SURGERY TIME WAS DELAYED AN HR AND A HALF. IT WAS CONFIRMED AT THE END OF THE PROCEDURE THAT THE DIAMETER OF THE ORVIL WAS TOO LARGE FOR THE PT'S ANATOMY. PT CURRENT CONDITION IS WELL.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SINGLE-USE STAPLER| PRODUCT ID#: EEAXL25