BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 18332233 · Received December 14, 2023

    Report

    Report Number
    3002808148-2023-14286
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 19, 2023
    Report Date
    January 19, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS, AND IT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION OF THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING, AND 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 DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION HAS BEEN ADDED TO THE FOLLOWING FIELDS: D8, D10, H4, AND H6. CORRECTION ON FIELDS: D9 AND H3. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO PERFORM AN ONSITE VISIT FOR AN INVESTIGATION OF THE ISSUE. THE FSE PERFORMED TROUBLESHOOTING BY TESTING THE UNIT, OPENING IT, AND CHECKING THAT THERE WAS NO MOISTURE OR TRACES OF MOISTURE. THE B30 (SCOPE COMMUNICATION) ERROR CODE APPEARED ONLY IN TWO SCOPES. THE CUSTOMER WAS INSTRUCTED TO SEND THE TWO SCOPES FOR REPAIR. (CF-HQ190I/COLONOVIDEOSCOPE/SN 2962451 AND GIF-HQ190/GASTROINTESTINAL VIDEOSCOPE/ SN (B)(6) ). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE B30 ERROR (COMMUNICATION ERROR) WAS CAUSED BY THE SCOPE, SINCE THE ERROR CODE WAS DISPLAYED ON ONLY TWO SCOPES. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE XENON LIGHT SOURCE DISPLAYED A B30-SCOPE COMMUNICATION ERROR CODE DURING A PROCEDURE. THE DEVICE WAS CLEANED SEVERAL TIMES, BUT THE ERROR PERSISTED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929054 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EVIS EXERA III COLONOVIDEOSCOPE| EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE