BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA ORVIL

    MDR report key: 1441377 · Received August 13, 2009

    Report

    Report Number
    MW5012445
    Event Type
    Malfunction
    Date Received
    August 13, 2009
    Date of Event
    August 10, 2009
    Report Date
    August 13, 2009
    Manufacturer
    TYCO HEALTHCARE / COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING A PARTIAL GASTRECTOMY FOR A GASTRIC CANCER. DURING PROCEDURE, THE ANVIL PORTION OF THE DEVICE BECAME DISCONNECTED FROM THE TUBE, AND WAS FOUND TO BE LODGED IN THE HYPOPHARYNX NEAR THE EPIGLOTTIS. GI CONSULTED, UNABLE TO REMOVE; HNS CONSULTED AND REMOVED UNDER DIRECT LARYNGOSCOPY. THERE WAS IRRITATION IN THE HYPOPHARYNX, BUT NO EVIDENCE OF PERFORATION, BLEEDING, OR SEVERE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA ORVIL EEA ORVIL25 GDW TYCO HEALTHCARE / COVIDIEN * U7J57

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR