BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 17368098 · Received July 20, 2023

    Report

    Report Number
    9610595-2023-10397
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 29, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS ONGOING. THE PHYSICAL DEVICE EVALUATION HAS BEEN COMPLETED. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. THE CUSTOMER PROVIDED THE CLEANING, DISINFECTION, AND STERILIZATION PROCESS STATING THAT PRECLEANING WAS PERFORMED IMMEDIATELY AFTER THE PROCEDURE. WATER WAS ASPIRATED THROUGH THE INSTRUMENT/ SUCTION CHANNEL WITH A SUCTION PUMP. AIR/WATER CHANNEL WAS FLUSHED WITH WATER AND AIR BY USING THE MH-948 AND THE DEVICE PASSED THE LEAK TEST. DURING MANUAL CLEANING, THE DETERGENT USED WAS 3EZYME. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, AND CHANNEL PORT WERE BRUSHED. THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) USED WAS GETINGE WITH APERLAN A OG B DISINFECTANT. THE WATER QUALITY WAS UNCONTROLLED AND THE FILTER WAS REPLACED PERIODICALLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS DRIED BY AER AND STORED IN A DRYING CABINET. OLYMPUS IS THE MAINTENANCE COMPANY. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND AFTER SAMPLING 5 SAMPLES AT 11:05 ON (B)(6) 2023 THERE WAS NO DETECTION OF E. COLI/OTHER ENTEROBACTERIACEA E, ENTEROCOCCI, R P. AERUGINOSA/ OTHER NON-FERMENTER, S. AUREUS/OTHER HYGIENE-RELEVANT BACTERIA, GREENING STREPTOCOCCI OR GERM DIFFERENTIATION. THE DEVICE EVALUATION FOUND THE AIR/WATER-CYLINDER HAD CORROSION. THE SUCTION COVER CASE UNIT HAD DISCOLORATION. THE PLUG UNIT HAD A SCRATCH. DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP DIRECTION DID NOT MEET THE STANDARD VALUE. THE LIGHT GUIDE LENS HAD A CRACK. ELECTRICAL TESTS PASSED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE INVESTIGATION IS ONGOING; THEREFORE, A ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 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. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. 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
    2108485 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLEANING BRUSH.| MH-948.| SUCTION PUMP.