BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15000522 · Received July 13, 2022

    Report

    Report Number
    8010047-2022-11820
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Report Date
    May 13, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305290
    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) HAD CONCERNS CONNECTED WITH FINDINGS OF DEVICES INSPECTED BY BORESCOPE AND THE REPROCESSING AT THE VARIOUS IU HEALTH FACILITIES. ARISING FROM THE FINDINGS, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE IU HEALTH FACILITIES BELOW: (B)(6) THE ASSOCIATED DEVICES/EVENTS THAT ARE IDENTIFIED AT THIS TIME FOR (B)(6) HOSPITAL INC. ARE AS BELOW: PATIENT IDENTIFIER , MODEL #, SERIAL NUMBER. (B)(6), CF-HQ190L, (B)(4). (B)(6), PCF-H190L, (B)(4). (B)(6), GIF-H190, (B)(4). (B)(6), GIF-H190, (B)(4). (B)(6), GIF-H190, (B)(4). (B)(6), PCF-H180AL, (B)(4). (B)(6), GIF-H190, (B)(4). (B)(6), GIF-1TQ160, (B)(4). THIS MEDWATCH IS FOR PATIENT IDENTIFIER: (B)(6). 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 DOES NOT ALWAYS USE THE AIR/WATER CHANNEL CLEANING ADAPTER DURING THE PRE-CLEANING. THE CUSTOMER LEAK TESTS THE SCOPE FOR ONLY 10 SECONDS AND DOES NOT ANGULATE THE CONTROL KNOBS. CUSTOMER DOES NOT REMOVE THE SCOPE FROM THE WATER PRIOR TO REMOVING THE LEAK TESTER FROM THE SCOPE CONNECTOR. THE SCOPE CONNECTOR IS THE ONLY PART REMOVED FROM THE WATER. THE LEAK TESTER IS ONLY DISCONNECTED FROM THE ETHYLENE OXIDE (EO OR ETO) ETO VALVE ON THE SCOPE AND IS NOT TURNED OFF OR PULLED FROM THE MU-1 UNIT TO DEPRESSURIZE THE SCOPE. 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 THIRD PARTY BRUSHES FROM MEDIVATORS. 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 MEDIVATOR¿S DSD 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

    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 WHITE FLECKS IN DEVICE MAY HAVE BEEN DUE TO THE DEVIATIONS OBSERVED. THE THREADY FOREIGN MATERIAL WAS FOUND AT THE DISTAL END HOWEVER, THE MATERIAL COULD NOT BE IDENTIFIED AND THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO THE USER¿S UNDERSTANDING DIFFERED FROM OLYMPUS RECOMMENDATION IN DEVICE HANDLING AND/OR REPROCESSING STEPS. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE.¿ 5.4 LEAKAGE TESTING OF THE ENDOSCOPE: ¿WITH THE LEAKAGE TESTER ATTACHED, IMMERSE THE ENDOSCOPE IN THE WATER AND OBSERVE FOR APPROXIMATELY 30 SECONDS WHILE DEFLECTING THE BENDING SECTION OF THE ENDOSCOPE BY TURNING THE ENDOSCOPE¿S UP/DOWN AND RIGHT/LEFT ANGULATION CONTROL KNOBS. CONFIRM THAT THERE IS NO LOCATION ON THE ENDOSCOPE FROM WHICH A CONTINUOUS SERIES OF AIR BUBBLES EMERGES.¿ ¿REMOVE THE ENDOSCOPE FROM THE WATER WITH THE LEAKAGE TESTER STILL ATTACHED.¿ ¿DETACH THE LEAKAGE TESTER FROM THE MAINTENANCE UNIT (MU-1) BEFORE DETACHING THE LEAKAGE TESTER FROM THE ENDOSCOPE. IF THE LEAKAGE TESTER IS DETACHED FROM THE ENDOSCOPE BEFORE DETACHING THE LEAKAGE TESTER FROM THE MAINTENANCE UNIT, THE AIR PRESSURE INSIDE THE ENDOSCOPE WILL NOT VENT PROPERLY. THIS MAY DAMAGE THE ENDOSCOPE.¿ BRUSHING STEPS ARE MENTIONED AT ¿5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES BRUSH THE CHANNELS¿. ¿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.¿ ¿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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE FOR THE SUBJECT DEVICE FROM FDF TO FDS.

    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 BLACK STAINING IN INSTRUMENT CHANNEL, A FEW WHITE FLECKS, AND THREADS AT DISTAL TIP. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS. CUSTOMER HAS RE-CLEANED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636422 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290
    701306 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown