BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS ULTRASONIC PROBE

    MDR report key: 6332627 · Received February 15, 2017

    Report

    Report Number
    6332627
    Event Type
    Death
    Date Received
    February 15, 2017
    Date of Event
    January 26, 2017
    Report Date
    February 10, 2017
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A HISTORY OF BRONCHIECTASIS AND PRIOR ASPERGILLUS INFECTION. CT ON (B)(6) 2017 REVEALED A PERIPHERALLY LOBULATED 3.0 X 2.1 X 3.1 CM CENTRAL CAVITARY LESION WITH POSITIVE FDG ACTIVITY RAISING A QUESTION OF A NEOPLASM. TRANSBRONCHIAL BIOPSY WAS PLANNED TO IDENTIFY THE LESION. HEPARIN WAS DISCONTINUED PRIOR TO THE PROCEDURE. NAVIGATIONAL BRONCHOSCOPY WITH A RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS) WAS EMPLOYED. AFTER INSERTION OF THE EBUS, THERE WAS DIFFICULTY PULLING BACK THE PROBE WHICH WAS NOTED TO BE COILED AT THE END OF THE BRONCHOSCOPE. THE SCOPE, PROBE AND SHEATH WERE REMOVED IN TOTO WITHOUT APPARENT PROBLEM AND, WERE INTACT. THE PT'S OXYGEN SATURATIONS DROPPED. BLOOD WAS NOTED COMING FROM THE MOUTH. THE BRONCHOSCOPE WAS INSERTED THROUGH THE ENDOTRACHEAL TUBE AND BLOOD SUCTIONED WITH IMPROVED VENTILATION. SUBCUTANEOUS EMPHYSEMA WAS NOTED AND A CHEST TUBE WAS INSERTED. THE PT DEVELOPED A WIDE COMPLEX ARRHYTHMIA AND ARRESTED. A CODE WAS CALLED. AFTER 49 MINUTES OF CPR, THE CODE WAS DISCONTINUED AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116813 OLYMPUS ULTRASONIC PROBE RADIAL ULTRASONIC PROBE ITX OLYMPUS AMERICA INC. UM-S20-17S

    Patients

    Seq Age Sex Outcome Treatment
    0 80 YR Death
    1 80 YR Death