BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVIGATION SYSTEM (DEVICE AVAILABLE)

    MDR report key: 4778932 · Received May 11, 2015

    Report

    Report Number
    4778932
    Event Type
    Death
    Date Received
    May 11, 2015
    Date of Event
    March 6, 2015
    Report Date
    May 8, 2015
    Manufacturer
    COVIDIEN, INC.
    Product Code
    EOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR NAVIGATIONAL BRONCHOSCOPY. THREE NAVIGATIONAL BRONCHO BIOPSY WERE TAKEN AND PLACED ON SLIDES. ALL 3 SAMPLES WERE NEGATIVE FOR CANCER. PT WITH KNOWN METASTATIC ADENOCARCINOMA. PROCEDURE DONE TO DIAGNOSE PRIMARY SITE. ADD'L BIOPSIES TAKEN FOR DIAGNOSIS. PT CONDITION STABLE THROUGHOUT PROCEDURE. A LARGE AMOUNT OF BLEEDING SUCTIONED THROUGH SCOPE AFTER OBTAINING LAST BIOPSY. PT O2 SAT DECLINED, PT WAS INTUBATED AND CPR STARTED. CODE CONTINUED FOR APPROX 1 HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308544 NAVIGATION SYSTEM (DEVICE AVAILABLE) SUPERDIMENSION NAVIGATION SYSTEM EOQ COVIDIEN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death DEVICE: EDGE 180 PROCEDURE, MFG: (B)(4)