BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 14135024 · Received April 18, 2022

    Report

    Report Number
    8010047-2022-06504
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 2, 2022
    Report Date
    June 28, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K202661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) OF THE SCOPE WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WAS CULTURED/TESTED. THE RESULTS WERE NOT AVAILABLE. THE AIR/WATER CHANNEL, AUXILIARY CHANNEL, BALLOON CHANNEL, AND FORCEPS ELEVATOR WIRE CHANNEL WERE FLUSHED WITHOUT DETERGENT. THERE WAS AN ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AS WELL. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, AND DISTAL END/AREAS AROUND THE ELEVATOR WERE MANUALLY CLEANED WITH ANIOSYME SYNERGY 5 DISINFECTANT AND AN ASEPT INMED BRUSH (REF # 201786). THE AER USED WAS A WSSSENBURG WD440 ALONG WITH ENDOHIGH DETERGENT AND ENDOHIGH PAA DISINFECTANT. THE SCOPE WAS STORED IN A WASSENBURG DRY320 DRYING CABINET. THE MAINTENANCE OF THE SCOPE WAS PERFORMED BY OLYMPUS. THE SCOPE WAS NOT STERILIZED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE INVESTIGATION IS ONGOING. THEREFORE; THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER; IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE HYGIENE MICROBIOLOGICAL INVESTIGATION PERFORMED ON BEHALF OF OLYMPUS, THE DEVICE EVALUATION, AND THE LEGAL MANUFACTURER¿S INVESTIGATION. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS, AND THE DISTAL END OF THE SCOPE WERE CULTURED. LESS THAN ONE (1) CFU OF A MICROORGANISM WAS DETECTED IN THE CHANNELS. ONE (1) CFU OF MICROCOCCACEAE WAS DETECTED IN THE DISTAL END. THE RESULTS OBTAINED COMPLIED WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE DEVICE WAS EVALUATED. THE REPORTED ISSUE WAS NOT CONFIRMED PER THE HYGIENE MICROBIOLOGICAL INVESTIGATION. DURING INSPECTION, IT WAS NOTED THE LIGHT GUIDE LENS GLUE HAD CHIPPED. THE BENDING SECTION COVER GLUE HAD SEPARATED. THE CONNECTING TUBE HAD A SCRATCH, AND THE UNIVERSAL CORD HAD A WRINKLE. THE LEGAL MANUFACTURER PERFORMED AN INVESTIGATION. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY SPECIFIED. RELATION BETWEEN THE EVENT AND THE DEVICE WAS NOT ABLE TO BE JUDGED FROM THE FOLLOWING INVESTIGATION RESULTS. ·WHEN THE USER HAD THE THIRD-PARTY LAB PERFORM THE CULTURE TEST, THE TEST RESULTED AS FOLLOWS: MAR 09, 2022: ALL CHANNELS: 50CFU/100ML_ KLEBSIELLA OXYTOCA. MAR 16, 2022: BIOPSY CHANNEL: 143CFU/100ML_STAPHYLOCOCCUS BOREALIS, STAPHYLOCOCCUS .HOMINIS, BREVUNDIMONAS DIMINUTA, KLEBSIELLA OXYTOCA. ·WHEN OLYMPUS TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE TEST RESULTED AS FOLLOWS: ALL CHANNELS: <1CFU/100ML DISTAL END: 1CFU/100ML_ MICROCOCCACEAE ·NO ABNORMALITY OR LEAKAGE FROM THE CHANNELS WAS CONFORMED ON THE SUBJECT DEVICE. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING GUIDELINES: REPROCESSING MANUAL:1.4 PRECAUTIONS: WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, A ROUTINE MICROBIOLOGICAL CULTURE WAS PERFORMED ON THE EVIS EXERA III DUODENOVIDEOSCOPE. (B)(6) 2022. ALL CHANNELS TESTED POSITIVE FOR EIGHTY-EIGHT COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS WARNERI, KLEBSIELLA OXYTOCA, AND BREVUNDIMONAS DIMINUTA. (B)(6) 2022. ALL CHANNELS TESTED POSITIVE FOR FIFTY CFUS OF KLEBSIELLA OXYTOCA. (B)(6) 2022. THE OPERATING CHANNEL/BIOPSY CHANNEL TESTED POSITIVE FOR ONE HUNDRED AND FORTY-THREE CFUS OF STAPHYLOCOCCUS BOREALIS, STAPHYLOCOCCUS HOMINIS, BREVUNDIMONAS DIMINUTA AND KLEBSIELLA OXYTOCA. THERE WAS NO CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640017 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown