BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 12583173 · Received October 6, 2021

    Report

    Report Number
    8010047-2021-12787
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 20, 2021
    Report Date
    April 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170339967
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION RECEIVED. PLEASE THE UPDATES IN SECTIONS. ADDITIONAL INFORMATION FROM THE FACILITY¿S GI LAB MANAGER STATES NO PATIENT INFECTION OCCURRED. SCOPE #(B)(4) CULTURED POSITIVE FOR ASPERGILLUS FUMIGATUS. NO SCOPES HAVE BEEN RECENTLY ETO STERILIZED. BEFORE EVERY WASH THE MINIMUM EFFECTIVE CONCENTRATION BEING CHECKED. THE ENDOSCOPE CHANNEL IS BEING BRUSHED WITH A SINGLE USE BRUSH DURING MANUAL CLEANING. PRE-CLEANING ON THE SCOPE IS BEING PERFORMED IMMEDIATELY AFTER A PROCEDURE. DOUBLE CLEANING IS BEING PERFORMED. THE ENDOSCOPE IS BEING LEAK TESTED PRIOR TO MANUAL CLEANING. THE SCOPE WAS NOT DROPPED OR DID NOT COME IN CONTACT WITH A HARD OBJECT. THE OER PRO AER IS BEING USED TO REPROCESS THE ENDOSCOPE. THERE HAVEN¿T BEEN ANY PROBLEMS NOTED WITH THE AER. THE LAST PM FOR THE AER WAS (B)(6) 2021. MULTIPLE TECHNICIANS REPROCESSED THIS SCOPE PRIOR TO POSITIVE CULTURE. THESE ARE TWO SCOPES WITH 4 DIFFERENT POSITIVE CULTURES. THE LAST REPROCESSING IN-SERVICE CONDUCTED BY AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST WAS (B)(6) 2021. ALL REPROCESSING PERSONNEL ARE TRAINED ON HOW TO PROPERLY REPROCESS AN ENDOSCOPE. THERE HAVE BEEN NO CHANGES IN THE FACILITIES REPROCESSING PERSONNEL SINCE THE LAST ON-SITE VISIT BY AN OLYMPUS ESS. THE ENDOSCOPE IS BEING STORED IN A HEPA FILTERED CABINET. THE FACILITY HAS (4) OER-PRO AUTOMATIC ENDOSCOPE REPROCESSORS ONSITE. IN ADDITION ON (B)(6) 2021, AN ENDOSCOPY SUPPORT SPECIALIST MET THE FACILITY¿S GI MANGER TO DISCUSS THEIR SCOPE FAILING CULTURE. THE CUSTOMER INFORMED THE ESS THAT THEY DID ANOTHER CULTURE AND THE SCOPE PASSED. THE ESS REPORTED THAT THE CUSTOMER UNDERSTOOD THAT SINCE THE CULTURING PROCESS WAS NOT WITHIN OLYMPUS PROTOCOL; THE CUSTOMER WAS GOING TO REVIEW THE HOSPITAL POLICIES AND THE MANUFACTURER'S GUIDELINES. A REPROCESSING IN-SERVICE WAS PREVIOUSLY GIVEN BACK IN (B)(6) 2021; HOWEVER, THE GI MANAGER WANTED TO SCHEDULE ANOTHER ONE FOR THE TEAM MEMBERS THAT MISSED IT. ON (B)(6) 2021, THE 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. THE ESS REPORTED THAT THE CUSTOMER CURRENTLY DOES NOT HAVE A PORTABLE SUCTION UNIT. THIS USED TO PERFORM THE SUCTION CLEANING WITH THE MH-856 DURING THE MANUAL CLEANING PHASE FOR THE ERCP TJF-Q180V. THE ESS REPORTED THAT THE FACILITY¿S GI MANAGER WILL BE IMPLEMENTING A NON-OLYMPUS SUCTION/FLUSHING UNIT SCOPE BUDDY PLUS SOON TO SATISFY THIS REQUIREMENT. THE CUSTOMER WILL ALSO BE USING THE OLYMPUS THE OER-PRO AUTOMATED REPROCESSING MACHINE TO PERFORM THE HIGH-LEVEL DISINFECTION. THE CUSTOMER ALSO UNDERSTOOD THAT THE OLYMPUS REPROCESSING MANUALS ARE THE VALIDATED SOURCE OF INSTRUCTIONS. PLEASE REFERENCE MFR. REPORT # 8010047-2021-13053.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LABORATORY RESULTS AND THE EVALUATION RESULTS ON THE DEVICE. THE LABORATORY RESULTS SHOWED THAT THE DEVICE TESTED POSITIVE FOR THE FOLLOWING MICROORGANISMS: BACILLUS SUBTILIS, BACILLUS SIAMENSIS, MICROCOCCUS YUNNANENSIS AND STAPHYLOCOCCUS CAPITIS. THESE MICROORGANISMS WERE RECOVERED FROM THE SAMPLES TAKEN FROM THE INSERTION SECTION, DISTAL END/ELEVATOR MECHANISM, AIR/WATER CHANNEL AND INSTRUMENT/SUCTION CHANNEL OF THE DEVICE. THE LABORATORY RESULTS DID NOT RECOVER ASPERGILLUS FUMIGATUS FROM THE DEVICE. AFTER THE LABORATORY TESTING, THE DEVICE WAS RETURNED TO OLYMPUS SERVICE CENTER FOR PHYSICAL EVALUATION. THE DEVICE WAS EXAMINED USING A BOROSCOPE AND FOUND THAT THE BIOPSY CHANNEL HAS LIGHT SCRAPE MARKS THROUGHOUT THE CHANNEL, STAINS WITHIN THE CONTROL BODY SECTION, AND KINK NEAR THE DISTAL END OPENING. THE SUCTION CHANNEL HAD KINK ON THE CHANNEL WALL NEAR THE CONNECTOR SIDE, BUT NO STAIN WAS NOTED. NO DEBRIS WAS NOTED IN THE FORCEPS ELEVATOR. THE BENDING SECTION COVER GLUE WAS DISCOLORED. THERE WERE SCRATCHES AND LIGHT STAINS NOTED ON THE DISTAL END. THE LIGHT GUIDE LENS HAS STAINS WITHIN. THE DEVICE PASSED THE LEAK TEST. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY.

    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, A ROOT CAUSE COULD NOT BE DETERMINED. WHEN OLYMPUS CULTURE TESTED BEFORE REPROCESSING BEFORE REPAIR, THE RESULTS CONFIRMED PRESENCE OF MICROORGANISMS. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, DETAILED INFORMATION WAS UNKNOWN FOR THE RESULT WAS NOT PROVIDED AND THEREFORE, CONFIRMATION OF THE SAME TYPE OF ORGANISMS WAS NOT POSSIBLE. THE STAINS WITHIN THE LIGHT GUIDE (LG) LENS WERE LIKELY CAUSED BY A GAP GENERATED BY PHYSICAL STRESS, FROM WHERE DIRT ENTERED. MOISTURE LIKELY ENTERED THE DEVICE, CAUSED CORROSION OF LG-LENS INNER PARTS. THE FOLLOWING IS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE (IFU): "WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." "DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT." "INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    AS PART OF OUR INVESTIGATION OF THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. TO DATE, THE ESS VISIT HAS NOT BEEN FINALIZED. THE SCOPE WAS RETURNED TO THE SERVICE CENTER AND IS PENDING EVALUATION. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING PREPARATION FOR USE, FOR A THERAPEUTIC PROCEDURE FUNGUS WAS OBSERVED ON THE SCOPE EVEN AFTER BEING REPROCESSED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482289 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170339967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown