BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 20261909 · Received September 19, 2024

    Report

    Report Number
    9610595-2024-18801
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 4, 2024
    Report Date
    October 18, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170434990
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND HISTORICAL COMPLAINTS ANALYSIS WAS CONDUCTED AND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE WAS IDENTIFIED. BASED ON THE RESULT OF THE INVESTIGATION, PHYSICAL STRESS WAS APPLIED TO THE INSERTION SECTION DURING USER HANDLING WHICH CAUSED THE CHARGED-COUPLE DEVICE (CDD) UNIT TO BE DAMAGED. THE DAMAGED CDD LIKELY CAUSED IMAGE ISSUES. THE EVENT CAN BE DETECTED AND PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE: 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 REPORTED, THE BRONCHOVIDEOSCOPE HAD AN IMAGE PROBLEM; B30 ERROR. THE ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    THE ISSUE OCCURRED MID-CASE DURING A SLEEP ENDOSCOPY PROCEDURE THAT WAS WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS A 5 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297463 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-XP190 04953170434990

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Female