BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 18646846 · Received February 5, 2024

    Report

    Report Number
    9610595-2024-02486
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 23, 2024
    Report Date
    April 1, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND AN ADDITIONAL REPORTABLE MALFUNCTION OF A B30 SCOPE ERROR. ADDITIONALLY, THE EVALUATION FOUND AN ABNORMAL SOUND BEING MADE DUE TO DETACHED PARTS INSIDE OF THE SCOPE CONNECTOR. 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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO EXTERNAL STRESS WAS APPLIED TO LOCK LEVER OF THE CONNECTING TUBE, WHICH LED TO BREAKAGE OF THE TUBE. THE EVENT CAN BE DETECTED AND PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) SECTIONS WHICH STATE: CHAPTER 5 INSPECTION AND PREPARATION BEFORE USE 5.7 INSPECTING THE CONNECTING TUBES AND LEAK TEST AIR TUBE BEFORE USING THE REPROCESSOR, ALWAYS CHECK THAT THERE IS NO IRREGULARITY REGARDING THE FOLLOWING POINTS ON THE CONNECTING TUBES AND LEAK TEST AIR TUBE. ALL TUBES SHOULD BE FREE OF CRACKS, BREAKS, FISSURES, SCRATCHES, OR STAINS. THERE SHOULD BE NO CRACKS IN THE LOCK LEVERS OF CONNECTING TUBE CONNECTORS AND LEAK TEST AIR TUBE CONNECTORS. THERE SHOULD BE NO BENDS OR BREAKS IN THE PIN OF CONNECTING TUBES CONNECTOR AND LEAK TEST AIR TUBE CONNECTOR. THE TUBE SHOULD NOT BE EASY TO DISCONNECT ONCE CONNECTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. MDR ADVERSE EVENT DECISION TREE # A24038676US2- COMPLAINT # (B)(4) SR# 232765 IT WAS REPORTED, THE BRONCHOVIDEOSCOPE HAD A BLACK SCREEN AND NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. PROVIDE NARRATIVE/DATA THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND AN ADDITIONAL REPORTABLE MALFUNCTION OF A B30 SCOPE ERROR. ADDITIONALLY, THE EVALUATION FOUND AN ABNORMAL SOUND BEING MADE DUE TO DETACHED PARTS INSIDE OF THE SCOPE CONNECTOR. 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. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE SCOPE CONNECTOR HAD A LEAK DURING USER HANDLING AND WATER INVADED THE SUBJECT DEVICE. 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 (EXCEPT BF-MP290F) 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 A BLACK SCREEN AND NO IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504364 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-Q290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown