BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15019912 · Received July 14, 2022

    Report

    Report Number
    8010047-2022-11965
    Event Type
    Malfunction
    Date Received
    July 14, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER (B)(6) UNIVERSITY HEALTH ((B)(6) HEALTH) FACILITIES HAD CONCERNS CONNECTED WITH REPROCESSING OF DEVICES AT THE VARIOUS (B)(6) HEALTH FACILITIES. ARISING FROM THIS CONCERN, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE (B)(6) HEALTH FACILITIES BELOW: (B)(6). THE ASSOCIATED DEVICES/EVENTS THAT ARE IDENTIFIED AT THIS TIME FOR (B)(6) UNIVERSITY HEALTH (B)(6) INC ARE AS BELOW: PATIENT IDENTIFIER: (B)(6), MODEL # GIF-H190, SERIAL NUMBER: (B)(4); (B)(6), GIF-H190, (B)(4); (B)(6), GIF-H190, (B)(4); (B)(6), GIF-H190, (B)(4); (B)(6), PCF-H190DL, (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 REMOVE THE SCOPE FROM THE WATER PRIOR TO DISCONNECTING THE LEAK TESTER FROM THE SCOPE. THE CUSTOMER USES THIRD PARTY BRUSHES FROM STERIS. 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 FOR FLUSHING AND THE MEDIVATORS ADVANTAGE 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. ON JULY 1, 2022, THE ENDOSCOPY SUPPORT SPECIALIST (ESS) RETURNED TO THE CUSTOMER¿S SITE AND PERFORMED A REPROCESSING IN-SERVICE WITH THE STAFF THAT COVERED THE GUIDELINES ON REPROCESSING THE OLYMPUS SCOPES PER THE ON-TRACK FORM AND REPROCESSING MANUAL. THE STAFF ALSO PERFORMED A RETURN DEMONSTRATION TO SHOW THEY UNDERSTOOD THE PROCESS. 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, IT¿S LIKELY THE DEBRIS ON THE CHANNEL WALL WAS CAUSED BY THE COMPETITORS¿ CLEANING BRUSH NOT TOUCHING ALL AREAS. BASED ON THE RESULTS OF THE INVESTIGATION, 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 METHODS AND 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: ¿REMOVE THE ENDOSCOPE FROM THE WATER WITH THE LEAKAGE TESTER STILL ATTACHED.¿ ¿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. IMMERSE THE ENDOSCOPE AND ACCESSORIES IN DETERGENT SOLUTION. LEAVE THE ENDOSCOPE WITH ATTACHED ACCESSORIES IMMERSED IN THE DETERGENT SOLUTION, ACCORDING TO THE INSTRUCTIONS OF 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 REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    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 FLAKING FOREIGN MATERIAL SETTLEMENT AT THE JUNCTION OF SUCTION CHANNEL AND UNIVERSAL CORD AND FRAYING AT DISTAL TIP. THE DEVICE IS SOAKED AND RE-CLEANED. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062453 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown