BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 15029567 · Received July 15, 2022

    Report

    Report Number
    8010047-2022-12015
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Report Date
    May 14, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. OLYMPUS ENDOSCOPY SUPPORT SPECIALIST PERFORMED AN IN-SERVICE AT THE FACILITY AND PROVIDED THE BELOW INFORMATION: THE CUSTOMER DOES NOT TEST THE LEAK TESTER PRIOR TO USE. CUSTOMER DOES NOT TAKE THE ENTIRE SCOPE OUT OF THE WATER BEFORE DISCONNECTING THE LEAK TESTER. THEY JUST REMOVE THE SCOPE CONNECTOR. THE BRUSHING IS DONE IN THE INCORRECT ORDER. THE CUSTOMER USED THIRD PARTY BRUSHES FROM STERIS. THE CUSTOMER IS NOT WIPING OFF THEIR BRUSH BRISTLES WHEN THEY COME OUT OF THE SCOPE AND PULL BACK OUT. THE CUSTOMER DOES NOT KEEP THE SCOPE IMMERSED THE ENTIRE TIME THEY ARE WIPING THE SCOPE DOWN. THE CUSTOMER DOES NOT USE THE CHANNEL OPENING CLEANING BRUSH IN THE SUCTION CYLINDER AND BIOPSY PORT. 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 USES INTERCEPT DETERGENT. THE CUSTOMER USES THE SCOPE BUDDY PLUS FOR FLUSHING AND THE MEDIVATORS ADVANTAGE AUTOMATIC ENDOSCOPY REPROCESSOR (AER). ALL CLEANING, DISINFECTION, AND STERILIZATION INFORMATION THAT WAS REVIEWED DURING IN-SERVICE WAS DOCUMENTED. MANAGER WAS PROVIDED WITH A COPY OF THE DOCUMENTATION FORMS VIA EMAIL. CUSTOMER WAS PROVIDED WITH WEBSITES INFORMATION FOR REPROCESSING VIDEOS. CUSTOMER WAS ADVISED TO FOLLOW ALL VALIDATED REPROCESSING METHODS LISTED IN THE REPROCESSING INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 0

    CUSTOMER (B)(6) FACILITIES HAD CONCERNS CONNECTED WITH REPROCESSING OF DEVICES AT THE VARIOUS (B)(6). ARISING FROM THIS CONCERN, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE (B)(6) BELOW: (B)(6). THIS IS THE ONLY DEVICE/EVENT THAT ARE IDENTIFIED AT THIS TIME FOR (B)(6) INC. IN-SERVICE IS BEING SCHEDULED BY THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) TO OBSERVE THE FACILITY¿S REPROCESSING OF ENDOSCOPES. CUSTOMER USES MEDIVATOR¿S ADVANTAGE PLUS REPROCESSORS, STERIS CLEANING BRUSHES, AND SCOPE BUDDY PLUS FOR SCOPE CLEANING. 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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, TO UPDATE D8, AND TO CORRECT D9. 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 COULD NOT BE DETERMINED. IT IS LIKELY THE USER¿S UNDERSTANDING DIFFERED FROM OLYMPUS RECOMMENDATION IN SCOPE HANDLING AND/OR REPROCESSING STEPS. THE USER¿S REPROCESSING STEPS DEVIATED FROM THE INSTRUCTIONS FOR USE (IFU) AS FOLLOWS: - THEY DO NOT TEST THE LEAK TESTER BEFORE USE. "5.4 LEAKAGE TESTING OF THE ENDOSCOPE WHEN ATTACHING THE CONNECTOR CAP OF THE LEAKAGE TESTER (MB-155) TO THE VENTING CONNECTOR OF THE ENDOSCOPE, MAKE SURE THAT BOTH THE CONNECTOR CAP AND THE VENTING CONNECTOR ARE THOROUGHLY DRY. WATER ON THE SURFACE OF EITHER COMPONENT MAY ENTER THE ENDOSCOPE AND COULD CAUSE ENDOSCOPE DAMAGE." - THEY DO NOT REMOVE THE SCOPE FROM WATER PRIOR TO DETACHING THE LEAK TESTER FROM THE SCOPE. THE SCOPE CONNECTOR IS THE ONLY PART REMOVED FROM THE WATER. THE STEPS FOR LEAKAGE TESTING DETAILED AT ¿5.4 LEAKAGE TESTING OF THE ENDOSCOPE. REMOVE THE ENDOSCOPE FROM THE WATER WITH THE LEAKAGE TESTER STILL ATTACHED." - THEY DO NOT FOLLOW THE CORRECT BRUSHING ORDER DURING MANUAL CLEANING. THEY DO NOT WIPE THE TIP OF THE BRUSH AFTER PULLING BACK OUT. - THEY DO NOT USE THE CHANNEL THE CHANNEL OPENING CLEANING BRUSH IN THE S- CYLINDER AND BIOPSY CHANNEL PORT. THE BRUSHING STEPS ARE DETAILED AT ¿5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES BRUSH THE CHANNELS¿. - THEY DO NOT KEEP THE SCOPE IMMERSED THE ENTIRE TIME THEY ARE WIPING IT DOWN. "5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES 1 FILL A CLEAN, LARGE BASIN WITH THE DETERGENT SOLUTION AT THE TEMPERATURE AND CONCENTRATION RECOMMENDED BY THE DETERGENT MANUFACTURER. 2 IMMERSE THE ENDOSCOPE IN THE DETERGENT SOLUTION." - THEY DO NOT WIPE THE SCOPE DOWN AFTER FLUSHING WITH DETERGENT SOLUTION AND DO NOT LET IT SOAK FOR THE DETERGENT MANUFACTURER'S RECOMMENDED TIME. "DRY EXTERNAL SURFACES: DRY THE EXTERNAL SURFACES OF THE ENDOSCOPE, THE CHANNEL PLUG, THE INJECTION TUBE, AND THE AUXILIARY WATER TUBE BY WIPING WITH CLEAN LINT-FREE CLOTHS." "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." - THE SCOPE IS NOT SOAKED AND GOES DIRECTLY INTO THE RINSE SINK. "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 GROSS DEBRIS WAS OBSERVED AT THE JUNCTION OF SUCTION CHANNEL AND UNIVERSAL CORD. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256121 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown