BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 14691153 · Received June 14, 2022

    Report

    Report Number
    8010047-2022-10036
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    May 4, 2022
    Report Date
    September 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    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 OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. ALL CHANNELS WERE SAMPLED. THE DEVICE TESTED POSITIVE FOR LESS THAN ONE (1) COLONY FORMING UNIT OF UNSPECIFIED MICRO-ORGANISMS. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE USER FACILITY PROVIDED ADDITIONAL INFORMATION REGARDING THE CLEANING, THE DISINFECTION AND THE STERILIZATION PROCESSES PERFORMED ONSITE FOR THE ENDOSCOPES. DURING PRE-CLEANING, THE CUSTOMER SUCTIONED WATER OUT OF THE CHANNELS AND FLUSHES OUT THE AIR/WATER CHANNEL, AUXILIARY WASHING CHANNEL, BALLOON AND THE FORCEPS ELEVATOR CHANNEL. DURING MANUAL CLEANING, THE CUSTOMER USED ENZYMEX DETERGENT WITH NEOCLEAN BRUSH TO BRUSH THE OPERATING CHANNEL, THE SUCTION PISTONS/CYLINDERS, THE OPERATING CHANNEL PORT, BALLOON CHANNEL AND THE DISTAL END/AREA AROUND THE FORCEPS ELEVATOR. THE SCOPE WAS NOT MANUALLY DISINFECTED. THE SCOPE WAS STORED IN A HORIZONTAL POSITION WITHIN A CABINET WITHOUT DRYING FUNCTION AND OLYMPUS IS THE CUSTOMER¿S MAINTENANCE COMPANY. THE SCOPE WAS NOT STERILIZED. THE CUSTOMER STATED THAT THE AUTOMATED ENDOSCOPE REPROCESSOR WAS TESTED BUT NO RESULTS WERE PROVIDED. THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE AWARE DATE SHOULD BE 11-MAY-2022. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. 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. THE FOLLOWING REPROCESSING METHODS ARE INCLUDED IN THE DEVICE IFU: CHAPTER "COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS." AND 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, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE TESTED POSITIVE FOR 8 COLONY FORMING UNITS (CFUS) OF ENTEROBACTERIA ON (B)(6) 2020, 9 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED MICRO-ORGANISMS ON (B)(6) 2020, GREATER THAN 100 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED MICRO-ORGANISMS ON (B)(6) 2020, ONE (1) COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA ON (B)(6) 2021, 50 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA ON (B)(6) 2021, 82 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA ON (B)(6) 2022 AND GREATER THAN 100 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA ON (B)(6) 2022. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. SAMPLING WAS TAKEN AT REPROCESSING. 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
    1627702 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown