BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 19149212 · Received April 19, 2024

    Report

    Report Number
    9610595-2024-08323
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 29, 2024
    Report Date
    June 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING AND RESULTS ARE STILL PENDING. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE CUSTOMER IS CURRENTLY BEING PERFORMED. AFTER CULTURE TESTING, THE DEVICE WILL BE EVALUATED. 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 MANUFACTURE'S (LM) REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES, RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION AND THE LMS FINAL INVESTIGATION. THE LM REVIEWED THE CUSTOMER PROVIDED THE CDS PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. THE DEVICE WAS EVALUATED, AND FOREIGN MATERIAL ADHERED TO THE AIR/WATER CYLINDER. BASED ON THE RESULTS OF THE INVESTIGATION AND BECAUSE THE USER CULTURE RESULTS WERE NOT SHARED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE REPORTED THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. THE REPORTED EVENT OF A POSITIVE CULTURE WAS NOT CONFIRMED AS THE SCOPE WAS NOT MICROBIOLOGICALLY TESTED BY OLYMPUS. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR A YEAST LIKE FUNGI DETECTED IN THE FORCEPS CHANNEL. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823308 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown