BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 3021633 · Received March 15, 2013

    Report

    Report Number
    1219930-2013-00198
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K062850
    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: ORVIL WAS STUCK AROUND HYPOPHARYNX WHEN IT WAS INSERTED, AND THE ANVIL HEAD WAS DETACHED WHILE THE SURGEON TUGGED THE BULB TIP FROM THE ABDOMINAL CAVITY. THE SURGEON ATTEMPTED TO CATCH THE ANVIL WITH FORCEPS, BUT IT DID NOT REACH. THEREFORE, ENDOSCOPE WAS INSERTED THROUGH THE MOUTH AND THE ANVIL WAS REMOVED BY GRASPING THE ANVIL SUTURE WITH ENDOSCOPIC FORCEPS. AFTER THAT, THE PROCEDURE WAS CONVERTED INTO OPEN, AND ANASTOMOSIS WAS PERFORMED WITH (B)(4) AND THE ANVIL SUPPLIED WITH THE STAPLER. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110448 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR N1E0635U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other