BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15027107 · Received July 15, 2022

    Report

    Report Number
    8010047-2022-11989
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 21, 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 INDIANA UNIVERSITY HEALTH (IU HEALTH) FACILITIES HAD CONCERNS CONNECTED WITH REPROCESSING OF DEVICES AT THE VARIOUS IU HEALTH FACILITIES. ARISING FROM THIS CONCERN, DEVICES/EVENTS HAVE BEEN IDENTIFIED FOR THE IU HEALTH FACILITIES BELOW: INDIANA UNIVERSITY HEALTH BEDFORD INC. INDIANA UNIVERSITY HEALTH BLOOMINGTON INC. BLOOMINGTON ENDOSCOPY CENTER LLC (BEC) INDIANA UNIVERSITY HEALTH MORGAN HOSPITAL INC. INDIANA UNIVERSITY HEALTH NORTH HOSPITAL INC. INDIANA UNIVERSITY HEALTH PAOLI INC. THE ASSOCIATED DEVICES/EVENTS THAT ARE IDENTIFIED AT THIS TIME FOR BLOOMINGTON HOSPITAL ARE AS BELOW: PATIENT IDENTIFIER MODEL NUMBER SERIAL NUMBER (B)(6) PCF-H190L (B)(4). (B)(6) PCF-H190L (B)(4). (B)(6) GIF-1TH190 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) SIF-Q180 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) GIF-H190 (B)(4). (B)(6) GF-UCT180 (B)(4). (B)(6) PCF-H190L (B)(4). (B)(6) TJF-Q190V (B)(4). (B)(6) TJF-Q190V (B)(4) (FIRST EVENT). (B)(6) TJF-Q190V (B)(4) (SECOND EVENT). 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 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. 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 ADVANTAGE PLUS PASS THROUGH 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. 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 AND TO UPDATE D8. 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. IN REGARDS TO THE BRUSH NOT REACHING AREAS OF THE CHANNEL, THE CAUSE COULD NOT BE SPECIFIED. THE USER¿S REPROCESSING STEPS DEVIATED FROM THE INSTRUCTIONS FOR USE (IFU) AS FOLLOWS: - THEY DO NOT FOLLOW THE CORRECT BRUSHING ORDER DURING MANUAL CLEANING. THE BRUSHING STEPS ARE DETAILED AT ¿5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES BRUSH THE CHANNELS¿. - 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 IS SLIGHT DIMPLING. 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
    1257073 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown