BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1201568 · Received October 17, 2008

    Report

    Report Number
    1219930-2008-00749
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP TOTAL GASTRECTOMY. PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: TWICE WHEN THE DEVICE WAS AT STUMP OF ESOPHAGUS, THE TUBE WAS REMOVED BUT THE ORVIL HAD DISENGAGED AND REMAINED IN THE PATIENT. THE ORVIL WAS THEN REMOVED FROM THE ESOPHAGUS WITH A CLAMP. ADDITIONAL RESECTION OF THE TISSUE WAS NEEDED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING WAS REPORTED. NO PATIENT INFORMATION WAS DISCLOSED.

    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 U8A71

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT#: U8F38H| EEA XL 25MM SINGLE-USE STAPLER| PRODUCT ID EEAXL25| EXP DATE: 06/30/2013