BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 15017506 · Received July 14, 2022

    Report

    Report Number
    8010047-2022-11942
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Report Date
    May 13, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170363672
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER (B)(6) FACILITIES HAD CONCERNS CONNECTED WITH REPROCESSING OF DEVICES AT THE VARIOUS (B)(6) FACILITIES. ARISING FROM THIS CONCERN, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE (B)(6) FACILITIES BELOW: (B)(6). THE ASSOCIATED DEVICES/EVENTS THAT ARE IDENTIFIED AT THIS TIME FOR BEC ARE AS BELOW: PATIENT IDENTIFIER (B)(6), MODEL NUMBER CF-HQ190L, SERIAL NUMBER (B)(4); (B)(6), PCF-H190DL, (B)(4); (B)(6), PCF-H190DL, (B)(4); (B)(6), PCF-H190DL, (B)(4); (B)(6), PCF-H190DL, (B)(4); THIS MEDWATCH IS FOR PATIENT IDENTIFIER: (B)(6), THIS DEVICE IS OWNED BY INDIANA UNIVERSITY HEALTH BLOOMINGTON INC.; HOWEVER, IT IS PHYSICALLY LOCATED AT BEC AND BEING USED AT THAT FACILITY. IN-SERVICE WAS PERFORMED BY THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) FOR THE FACILITY¿S REPROCESSING. THE CLEANING, DISINFECTION, AND STERILIZATION INFORMATION WAS REVIEWED DURING IN-SERVICE AND DOCUMENTED. BELOW ARE THE OBSERVATIONS MADE: DURING REPROCESSING IN-SERVICE IT WAS OBSERVED THAT THE CUSTOMER KEEPS THE AUXILIARY WATER TUBE ON DURING LEAK TESTING. THE CUSTOMER DOES NOT USE LINT FREE CLOTHS DURING THE MANUAL CLEANING PROCESS. THE CUSTOMER USES THE CHANNEL OPENING CLEANING BRUSH PRIOR TO USING THE CHANNEL CLEANING BRUSH. THE BRUSHING IS DONE IN THE INCORRECT ORDER. THE CUSTOMER USES OLYMPUS BRUSHES. THE CUSTOMER ALSO DOES NOT WIPE THE SCOPE DOWN AFTER THE FLUSHING WITH DETERGENT SOLUTION AND DOES NOT LET IT SOAK FOR THE DETERGENT MANUFACTURER'S RECOMMENDED TIME. THE SCOPE DOES NOT SOAK AT ALL AND GOES DIRECTLY INTO THE RINSE SINK. THE CUSTOMER DOES NOT ALWAYS KEEP THE SCOPE IMMERSED WHILE REPROCESSING AND BRUSHING. THE CUSTOMER USES PURE DETERGENT. THE CUSTOMER USES THE SCOPE BUDDY PLUS FOR FLUSHING AND THE MEDIVATOR¿S EDGE AUTOMATIC ENDOSCOPY REPROCESSOR (AER). THE CORRECT REPROCESSING METHOD PER THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED IN THE IN-SERVICE. CUSTOMER MANAGER WAS PROVIDED WITH A COPY OF THE DOCUMENTATION OF THE IN-SERVICE, POSTERS, AND WEBSITES FOR REPROCESSING VIDEOS. CUSTOMER WAS ADVISED TO FOLLOW ALL VALIDATED REPROCESSING METHODS LISTED IN THE REPROCESSING IFU. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: D9 - NO SHOULD HAVE BEEN SELECTED ON THE INITIAL REPORT RATHER THAN YES. 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, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. THERE WERE CONFIRMED DEVIATIONS FROM THE INSTRUCTIONS FOR USE (IFU). IT IS LIKELY THAT THERE WAS A DIFFERENCE IN THE HANDLING OF EQUIPMENT AND RECOGNITION OF REPROCESSING PROCEDURES BETWEEN OLYMPUS' RECOMMENDATIONS AND THE FACILITIES CONCERNED. IT WAS ALSO CONFIRMED THERE IS A PLACE IN THE SCOPE CHANNEL THAT THE CLEANING BRUSH DOES NOT HIT. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: 1) 5.4 LEAKAGE TESTING OF THE ENDOSCOPE DESCRIBES THE PROCEDURE FOR LEAK TESTING IN DETAIL. 2) "ALL CLOTHS USED IN REPROCESSING ARE RECOMMENDED TO BE LINT-FREE. LINT OR CLOTH FIBERS SHED INTO REPROCESSING FLUIDS MAY BE INJECTED INTO THE ENDOSCOPE CHANNELS. THERE IS THE POTENTIAL FOR LINT OR CLOTH FIBERS TO LODGE IN CHANNELS OR BECOME TRAPPED IN THE AIR/WATER NOZZLE. IF GAUZE IS USED TO REPROCESS THE ENDOSCOPE, ENSURE THAT FIBERS DO NOT GET CAUGHT ON OR REMAIN TRAPPED BY PROTRUDING COMPONENTS LIKE THE AIR/WATER NOZZLE." 3) 5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES BRUSH THE CHANNELS DESCRIBES THE BRUSHING PROCEDURE. 4) 5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES FILL A CLEAN, LARGE BASIN WITH THE DETERGENT SOLUTION AT THE TEMPERATURE AND CONCENTRATION RECOMMENDED BY THE DETERGENT MANUFACTURER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, CONCERN WAS RAISED FOR THE REPROCESSING ACROSS MULTIPLE CUSTOMER SITES UPON FINDINGS AFTER DEVICES WERE INSPECTED WITH A BORESCOPE. THE FINDINGS OF A BORESCOPE INSPECTION FOR THIS DEVICE ARE YELLOW STAINING ON INSERTION TUBE NUMBERS AND FOREIGN MATERIAL SEDIMENT AT THE JUNCTION OF SUCTION CHANNEL AND UNIVERSAL CORD. THE BORESCOPE WAS PUT IN THE DEVICE BACKWARD THROUGH THE SUCTION CONNECTOR (CHRISTMAS TREE TYPE) ON THE SCOPE CONNECTOR AND ALL OF THE WAY UP WHERE THE UMBILICAL CORD MEETS THE CONTROL BODY. IT WAS OBSERVED THAT THE BRUSHES DID NOT TOUCH THE CHANNEL WALL ON THE SIDE THAT THE DEBRIS IS BEING FOUND. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464282 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190DL 04953170363672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown