BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 15972588 · Received December 13, 2022

    Report

    Report Number
    9610595-2022-05357
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 16, 2022
    Report Date
    February 22, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE ALSO SEE B3 FOR UPDATES. 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, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THEIR CLEANING, DISINFECTION, AND STERILIZATION PROCESS STATING THE MANUAL CLEANING DETERGENT IS ANIOS CLEAN EXEL D. THE CUSTOMER ASPIRATES WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AND FLUSHES OUT THE AIR/WATER AND AUXILIARY CHANNELS. DURING MANUAL CLEANING, THE CUSTOMER BRUSHES THE INSTRUMENT/SUCTION, THE SUCTION CYLINDER AND THE INSTRUMENT CHANNEL PORT USING THE BRUSH ASEPT-INMED(REF 201792 LOT 220206). MANUAL DISINFECTION WAS NOT PERFORMED. THE CUSTOMER USES AUTOMATED ENDOSCOPIC REPROCESSOR (AER) MODEL 8142072, ALONG WITH DETERGENT ENDOBET, AND DISINFECTANT ENDODIS. THE AER WAS NOT TESTED; HOWEVER PRE-CHECK WAS PERFORMED ON 18-NOV-22. THE ENDOSCOPE WAS STORED HORIZONTALLY. THE MAINTENANCE AND REPAIR WAS PERFORMED BY OLYMPUS. THE ENDOSCOPE WAS NOT STERILIZED. THE DEVICE WAS RETURNED. PRIOR TO THE DEVICE EVALUATION, THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. THE DEVICE TESTED POSITIVE FOR LESS THAN ONE (1) COLONY FORMING UNITS OF MICRO ORGANISM. OVERALL, THE RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE RETURNED DEVICE WAS INSPECTED. DURING INCOMING INSPECTION THERE WERE NO FINDINGS. THE PRODUCT WAS SENT BACK TO THE CUSTOMER WITHOUT ANY REPAIR. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA LL COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT FROM THE CUSTOMER INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND MORE THAN 80 COLONY FORMING UNITS (CFU) PER 100 MILLILITER OF PSEUDOMONAS AERUGINOSA WAS IDENTIFIED. 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
    1438461 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-Q180AI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown