BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 15327815 · Received August 31, 2022

    Report

    Report Number
    9610595-2022-01473
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    July 25, 2022
    Report Date
    November 10, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED BUT THE EVALUATION IS NOT YET COMPLETED. AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS THE INFORMATION BECOMES AVAILABLE. AN INDEPENDENT LABORATORY PERFORMED FOR OLYMPUS A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED PER THE DIRECTIONS OF THE INSTRUCTIONS FOR USE. THE TEST RESULTS INDICATE THAT THE CULTURE SAMPLING RESULTS FOR ALL CHANNELS CONFORM TO THE TARGET LEVELS ESTABLISHED BY THE FRENCH REGULATION OF (B)(6) 2016 WITH A NUMBER OF REVIVABLE MICROORGANISMS LESS THAN 1 CFU/ENDOSCOPE. CUSTOMER PROVIDED INFORMATION OF THEIR REPROCESSING METHOD. DURING PRE-CLEANING, SUCTION IS PERFORMED FOR ALL CHANNELS AND RINSING IS PERFORMED FOR THE AIR WATER CHANNEL, AUXILIARY CHANNEL, BALLOON CHANNEL, AND ERECTOR CHANNEL. DETERGENT USED IS HEXIANOS. DURING MANUAL CLEANING DETERGENT AND DISINFECTANT USED ARE HEXIANOS. BRUSHING IS PERFORMED FOR THE INSTRUMENT CHANNEL, SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, AND DISTAL/AREAS AROUND THE ELEVATOR. MODEL NUMBER OF THE BRUSHES USED ASEPTINMED (REF (B)(4), LOT 220249). AUTOMATIC ENDOSCOPY REPROCESSOR (AER) DEVICE IS WASSENBURG. DETERGENT USED WITH IT IS ENDOHIGH AND DISINFECTANT USED IS ENDOHIGH PAA. THE DEVICE IS STORED VERTICALLY IN A SIMPLE CABINET WITHOUT DRYING FUNCTIONALITY. MAINTENANCE OF THE DEVICE IS BY OLYMPUS. THE DEVICE WAS STERILIZED MANUALLY WITH PERACETIC ACID.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO SERVICE WHERE EVALUATION FOUND WEAR AND TEAR: THE LIGHT GUIDE LENS WAS CRACKED, THE OBJECTIVE LENS WAS CRACKED, THERE WAS A GAP OF ADHESIVE ON THE RUBBER, THERE WAS DETERIORATION OR DISCOLORATION, AND THE ANGLE WIRES WERE STRETCHED. NONE OF THESE ISSUES ARE REPORTABLE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO DETERMINE THE RELATION BETWEEN THE SUBJECT DEVICE AND THE EVENT FROM THE INVESTIGATION RESULTS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (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 THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED BY THE CUSTOMER, AFTER A MICROBIOLOGICAL ROUTINE SAMPLING OF THIS DEVICE, CARRIED OUT AS REQUIRED BY FRENCH REGULATION, UNEXPECTED CONTAMINATION WAS DETECTED WHICH WAS ABOVE THE ACCEPTABLE THRESHOLD. THE TEST WAS PERFORMED PRIOR TO USE. THERE WAS NO CONTAMINATION OR ANY OTHER DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068500 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown