BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 17097434 · Received June 9, 2023

    Report

    Report Number
    9610595-2023-08653
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Report Date
    August 11, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170342134
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY PHYSICAL STRESS WAS APPLIED TO THE INSERTION SECTION DURING HANDLING OF THE DEVICE BY THE USER. THAT SQUASHED THE INSERTION SECTION, OBSTRUCTED MOVEMENT OF CABLE OF THE IMAGE SENSOR UNIT, AND CAUSED DAMAGE. AS A RESULT, THE IMAGE FLICKERED DURING ANGULATION. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE (IFU): ¿-INSPECTION OF THE ENDOSCOPIC IMAGE -DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CABLE, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CABLE, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO AN OLYMPUS REPAIR FACILITY, AND AN EVALUATION WAS PERFORMED. UPON INSPECTION AND TESTING, THE CCD (CHARGED COUPLED DEVICE) IMAGE FLICKERED WHEN ANGULATING. IN ADDITION, A ¿SQUASHED¿ INSERTION TUBE WAS DISCOVERED. THE DEVICE WAS DISASSEMBLED, ALL DURABLE COMPONENTS WERE INSPECTED, THEN REASSEMBLED. A NEW INSERTION TUBE UNIT WAS INSTALLED, INCLUDING ALL INTERNAL INSERTION TUBE COMPONENTS: CCD WITH OBJECTIVE LENSES, FOUR ANGULATION WIRES, LIGHT GUIDE BUNDLE WITH LENSES, AIR/ WATER CHANNEL, AND BIOPSY (SUCTION) CHANNEL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED INTERMITTENT IMAGE LOSS WHEN ARTICULATING WITH THE EVIS EXERA III BRONCHOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM. UPON INSPECTION AND TESTING OF THE DEVICE, THE CCD (CHARGED COUPLED DEVICE) IMAGE FLICKERED WHEN ANGULATING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270641 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-XP190 04953170342134

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown