BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 15592143 · Received October 12, 2022

    Report

    Report Number
    3002808148-2022-03093
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 12, 2022
    Report Date
    January 4, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS ONGOING. THE PHYSICAL DEVICE EVALUATION HAS NOT BEEN COMPLETED. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL CULTURAL TESTING. THE MICROBIOLOGICAL ANALYSIS RESULTS ARE PENDING. THE CUSTOMER PROVIDED THE CLEANING, DISINFECTION, AND STERILIZATION PROCESS STATING THE PRE-CLEANING DETERGENT IS ANIOSYNEX3 AND THE AUTOMATED ENDOSCOPIC REPROCESSOR (AER) USED IS OLYMPUS MT4. THE AIR/WATER CHANNEL, AUXILIARY CHANNEL, BALLOON CHANNEL, AND FORCEPS ELEVATOR WIRE CHANNEL WERE ASPIRATED AND FLUSHED WITH WATER. THE AER DETERGENT IS ENDODET OLYMPUS AND THE AER DISINFECTANT IS ENDODIS OLYMPUS. THE MANUAL DETERGENT IS ANIOSYNEX3 AND NO MANUAL DISINFECTANT IS USED. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, AND DISTAL END WERE BRUSHED USING ASEPTINMED 201693 AND 201790 MANUAL BRUSHES. THE STORAGE PRACTICE IS USING A SIMPLE CABINET, AND OLYMPUS IS THE MAINTENANCE COMPANY. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESULTS OF THIRD PARTY TESTING, THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. A FEW DEFECTS WERE NOTED WHERE THE LIGHT GUIDE COVER LENS GLUE WAS WORN AND TORN AND THE PROBE UNIT WAS DAMAGED. HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION WITH NO GERMS DETECTED. THE INSTRUCTION MANUAL OF GF-UCT180 WAS REVIEWED. IT DESCRIBES THE REPROCESSING METHODS IN THE FOLLOWING CHAPTERS: CHAPTER "COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS" CHAPTER "CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES" OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE TESTED POSITIVE FOR OVER 100 COLONY FORMING UNITS (CFUS) OF ESCHERICHIA COLI. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN 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
    1842658 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown