BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 18632039 · Received February 2, 2024

    Report

    Report Number
    9610595-2024-02320
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    November 16, 2023
    Report Date
    March 1, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170434983
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND A FAILED LEAK TEST, A FAILED PROBE COVER INSULATION, A MISSING BENDING SECTION COVER GLUE, PEELED CEMENT ON THE OBJECTIVE LENS, A PEELED LABEL AND A MISSING IPX-7. THE FOLLOWING COMPONENTS OF THE DEVICE WERE NON OLYMPUS: PLASTIC DISTAL END COVER, BENDING SECTION COVER, AND THE INSERTION TUBE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED, AND AN EVALUATION WAS COMPLETED. A REVIEW OF DEVICE HISTORY RECORD AND HISTORICAL COMPLAINTS ANALYSIS WAS CONDUCTED AND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE WERE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, WHILE THE USER WAS HANDLING THE DEVICE, BENDING SECTION COVER LEAKED, WHICH LED TO WATER INVASION OF THE DEVICE, THEN ABNORMALITY OF ELECTRONIC PARTS. SUBSEQUENTLY, NO IMAGE OCCURRED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE (IFU): ¿IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE ¦PRECAUTIONS: CAUTION "TURN THE VIDEO SYSTEM CENTER ON ONLY WHEN THE ENDOSCOPE CONNECTOR IS CONNECTED TO THE LIGHT SOURCE. IN PARTICULAR, CONFIRM THAT THE VIDEO SYSTEM CENTER IS OFF BEFORE CONNECTING OR DISCONNECTING THE ENDOSCOPE CONNECTOR. FAILURE TO DO SO CAN RESULT IN EQUIPMENT DAMAGE, INCLUDING DESTRUCTION OF THE IMAGE SENSOR". ¦PRECAUTIONS FOR DISAPPEARED OR FROZEN ENDOSCOPIC IMAGE: WARNING "FOLLOW THE PRECAUTIONS GIVEN BELOW. OTHERWISE, THE ENDOSCOPIC IMAGE MAY DISAPPEAR UNEXPECTEDLY, OR THE FROZEN IMAGE MAY NOT BE RESTORED DURING THE EXAMINATION".. 3.8 "INSPECTION OF THE ENDOSCOPIC SYSTEM" ¦"INSPECTION OF THE ENDOSCOPIC IMAGE" "CONFIRM THAT THE WLI AND NBI ENDOSCOPIC IMAGES ARE NORMAL". 5.1 "TROUBLESHOOTING" "IF ANY IRREGULARITY IS OBSERVED DURING THE INSPECTION DESCRIBED IN CHAPTER 3, ¿PREPARATION AND INSPECTION¿, DO NOT USE THE ENDOSCOPE AND SOLVE THE PROBLEM AS DESCRIBED IN SECTION 5.2,¿TROUBLESHOOTING GUIDE¿. IF THE PROBLEM STILL CANNOT BE RESOLVED, SEND THE ENDOSCOPE TO OLYMPUS FOR REPAIR AS DESCRIBED IN SECTION 5.4, ¿RETURNING THE ENDOSCOPE FOR REPAIR.¿ ALSO, SHOULD ANY IRREGULARITY BE OBSERVED WHILE USING THE ENDOSCOPE, STOP USING IT IMMEDIATELY AND WITHDRAW THE ENDOSCOPE FROM THE PATIENT AS DESCRIBED SECTION 5.3, ¿WITHDRAWAL OF THE ENDOSCOPE WITH AN IRREGULARITY¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232650 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P190 04953170434983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown