BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 3802335 · Received February 21, 2014

    Report

    Report Number
    2951238-2014-00058
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THAT THE ENTIRE DISTAL END WAS MISSING. THE LIGHT GUIDE BUNDLES, CHARGE COUPLE DEVICE (CCD) UNIT, AND BIOPSY CHANNEL WERE EXPOSED. THIS PHENOMENON WAS DUE TO MECHANICAL OVERLOAD. IN ADDITION, PHYSICAL DAMAGE WERE OBSERVED ON THE BENDING SECTION, INSERTION TUBE AND DISTAL BLACK COATING. THE DEVICE WAS REFURBISHED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AT THE END OF THE THERAPEUTIC BRONCHOSCOPY PROCEDURE, AND WHEN THE BRONCHOSCOPE WAS BEING WITHDRAWN THE DISTAL END OF THE BRONCHOSCOPE BECAME STUCK IN THE ENDOTRACHEAL TUBE. A PIECE OF THE BLACK RUBBER TUBE FROM THE DISTAL END FELL INTO THE PATIENT'S LUNGS. THE BLACK RUBBER TUBE WAS RETRIEVED USING ANOTHER BRONCHOSCOPE AND A BIOPSY FORCEPS. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108873 EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORP BF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ENDOTRACHEAL TUBE