BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17940886 · Received October 16, 2023

    Report

    Report Number
    9610595-2023-15234
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 26, 2023
    Report Date
    December 15, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE CUSTOMER STATED THE FOLLOWING: 1. YES, BEDSIDE PRE-CLEANING = WIPE DOWN SCOPE FROM CLEANEST TO DIRTIEST. THEN SUCTION, REMOVE A/W (AIR/WATER) BUTTON, PUT IN AND HOLD DOWN (PRESS) KEY, WAIT AND THEN FOOT PEDAL. TURN OFF, DISCONNECT AND REMOVE SCOPE. REPROCESSING ROOM = CONNECT TO LEAK TESTER, PLACE IN SINK, WAIT FOR ALL BUBBLES TO STOP. CHECK DISTAL TIP/ANGULATION AND REMOVE FROM SINK. TURN LEAK TESTER OFF AFTER REMOVING SCOPE FROM SINK. SIX PUMPS OF ENZYMATIC INTO SINK, DISCONNECT SCOPE FROM LEAK TESTER AND PLACE IN SINK. GRAB CLEAN SPONGE AND WIPE DOWN SCOPE FROM CLEANEST (COMPUTER) TO DIRTIEST (DISTAL TIP) W/O GOING BACKWARDS. THROW AWAY SPONGE AND GET CLEAN BRUSH. START WITH FAT END AND GO IN THE SUCTION CHANNEL AND BIOPSY CHANNEL. TAKE SKINNY END OF BRUSH AND GO DOWN SUCTION CHANNEL (TO THE RIGHT) TO COME OUT DISTAL TIP, REPEAT TWO TIMES OR MORE IF NEEDED UNTIL CLEAN. THEN GO DOWN SUCTION CHANNEL (STRAIGHT) TO COME OUT THE SUCTION PORT TWO TIMES OR MORE IF NEEDED. FINALLY GO DOWN THE BIOPSY CHANNEL TWO TIMES OR MORE IF NEEDED. REMOVE CLEANING BRUSH AND THROW AWAY. CHECK SCOPE IN MAGNIFIER TO CHECK FOR DAMAGE, CRACKS, ETC. DRAIN SINK AND THE SCOPE IS NOW READY FOR THE OER (OLYMPUS ENDOSCOPE REPROCESOR). 2. ENZYMATIC DETERGENT MANUFACTURED BY ECOLAB. UNSURE OF MODEL. 3. TESTED PRIOR TO EACH USE. 4. ENDOSCOPES ARE LEAK TESTED WITH THE OLYMPUS MU - 1 LEAKAGE TESTER. 5. YES, ENDOSCOPE CHANNEL IS BEING BRUSHED DURING MANUAL CLEANING WITH A SINGLE USE BRUSH. 6. THE MANUFACTURER FOR THE BRUSH IS DIVERSATEK HEALTHCARE. MODEL IS CLEANFREAK ENDOSCOPE CLEANING BRUSH. 7. THE AER (AUTOMATED ENDOSCOPE REPROCESSORS) BEING USED IS THE OLYMPUS OER - PRO WITH SERIAL NUMBER (B)(6). 8. NO NOTED PROBLEMS. 9.DISINFECTANT SOLUTION IS CALLED ENDOQUICK MANUFACTURED BY OLYMPUS. 10. TESTED PRIOR TO EACH USE. 11. LAST REPROCESSING IN-SERVICE WAS (B)(6) AND THE ONE BEFORE THAT WAS (B)(6) 2023. 12. NO CHANGE IN PERSONNEL. 13. YES ALL PERSONNEL ARE TRAINED ON SCOPE HANDLING. 14. ENDOSCOPES GET STORED IN THE HANGING CLOSET. 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 FOREIGN MATERIAL WAS UNABLE TO BE IDENTIFIED AND THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU): OPERATION MANUAL 3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM INSPECTION OF THE WATER FEEDING FUNCTION 1 KEEP THE AIR/WATER VALVE¿S HOLE COVERED WITH YOUR FINGER. 2 DEPRESS THE VALVE. OBSERVE THE ENDOSCOPIC IMAGE AND CONFIRM THAT WATER FLOWS ON THE ENTIRE OBJECTIVE LENS. 3 RELEASE THE AIR/WATER VALVE. WHILE OBSERVING THE ENDOSCOPIC IMAGE, CONFIRM THAT THE EMISSION OF WATER STOPS AND THAT THE VALVE RETURNS SMOOTHLY TO ITS ORIGINAL POSITION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED; THE AIR/WATER CHANNEL WAS CLOGGED. THE EVALUATION FINDINGS WERE AS FOLLOWS: THE ANGULATION WAS LOW, THE CONTROL KNOB MOVEMENT "UP/DOWN" AND "RIGHT/LEFT" HAD PLAY (LOOSE), THERE WERE SCRATCHES AND DENTS IN THE PLASTIC DISTAL END COVER, THE BENDING SECTION COVER HAD CRACKS AND DISCOLORATION ON BOTH SIDES, AND THE LIGHT GUIDE TUBE HAD A MINOR BUCKLE. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, THE WATER WAS NOT PUSHING THROUGH THE AIR/WATER BUTTON ON THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631929 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown