BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 3874829 · Received May 30, 2014

    Report

    Report Number
    1219930-2014-00432
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GAG
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: WHEN REMOVING THE INSTRUMENT FROM THE CUT EDGE OF THE ESOPHAGUS, THE TUBE SECTION DETACHED AND THE ANVIL WITH THE WHITE PLASTIC PIECE WAS LEFT IN THE CAVITY. THE ANVIL WAS FOUND IN THE ORAL CAVITY AND WAS REMOVED WITH FORCEPS. USING ANOTHER DEVICE, THE CUT EDGE WAS ADDITIONALLY RESECTED TO PERFORM ANOTHER ANASTOMOSIS TO COMPLETE THE CASE. PIECES FELL INTO THE CAVITY AND COULD BE RETRIEVED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS UNANTICIPATED TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318921 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GAG COVIDIEN LP, FORMERLY US SURGICAL N3K1721UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other