BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 3981516 · Received July 25, 2014

    Report

    Report Number
    1219930-2014-00562
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K093402
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP ASSISTED PROXIMAL GASTRECTOMY. ACCORDING TO THE REPORTER: THE DEVICE WAS INSERTED ORALLY AND REMOVED FROM THE CAVITY. HOWEVER, WHEN REMOVING, A DOCTOR FOUND THE ANVIL REMAINED IN THE PT. THE PT WAS X-RAYED AND THE ANVIL WAS CONFIRMED TO BE LEFT IN THE THROAT AREA. WITH THE ASSISTANCE OF THE LARYNGOSCOPE, THE ANVIL WAS REMOVED WITH NO DAMAGE. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS AN EXTENSION OF OPERATING TIME BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436710 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY UNITED STATES N3B0051UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other