BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17767752 · Received September 18, 2023

    Report

    Report Number
    9610595-2023-13545
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 16, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS, AND THE PHYSICAL DEVICE EVALUATION HAS NOT BEEN COMPLETED. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. THE MICROBIOLOGICAL ANALYSIS RESULTS ARE PENDING. THE CUSTOMER PROVIDED THE CLEANING, DISINFECTION, AND STERILIZATION PROCESS, STATING THAT THE ENDOSCOPE HAD NOT BEEN STERILIZED. THE TEST PERFORMED WAS REPORTED ON THE ENDOSCOPE. AN AER/EWD ENDOSCOPE WASHER TEST HAD BEEN CARRIED OUT. NO PATIENT INFECTIONS WERE FOUND. THE DECONTAMINATION AND PRELIMINARY CLEANING STEPS PERFORMED AT THE WATER SUCTION THROUGH THE SUCTION/OPERATING CHANNEL, CALIPER ELEVATOR CONTROL CABLE CHANNEL, AND AUXILIARY CHANNEL WERE WASHED WITH AIR AND WATER. THE DETERGENT USED FOR CLEANING WAS DIAL 2-LMA PLURI. BRUSHED POINTS INCLUDED THE SUCTION CHANNEL, WORKING AND SUCTION BARREL, WORKING CHANNEL INLET AND DISTAL END, AND AREAS AROUND THE ELEVATOR. MANUAL BRUSHING OCCURRED WITH AN OLYMPUS BRUSH AND WAS STERILIZED IN AN AUTOCLAVE AT THE FACILITY. MANUAL DISINFECTION HAD BEEN CARRIED OUT WITH DIAL 2-LMA PLURI. AER/EWD MODEL (ENDOSCOPE WASHER) AND CLIMATE PRODUCTS USER WERE MODEL ISA MEDIVATORS, DETERGENT NAME: ISACLEAN, AND NAME OF DISINFECTION WAS ADOSPOR. THE ENDOSCOPE WAS STORED IN A SIMPLE CABINET WITHOUT A DRYING FUNCTION. THE MAINTENANCE AND REPAIR WERE CARRIED OUT BY OLYMPUS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION, AND THE PHYSICAL DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE EVALUATION FOUND AIR, WATER, AND SUCTION CYLINDERS HAD NO COLOR; THE PLASTIC DISTAL END COVER HAD DISCOLORATION; THE ADHESIVE ON THE BENDING SECTION COVER HAD WEAR; THE CONNECTING TUBE HAD BUCKLING; DUE TO THE WEAR OF THE ANGLE WIRE, THE BENDING ANGLE IN THE UP DIRECTION DID NOT MEET THE STANDARD VALUE; AND THE WATER CHANNEL WAS DEFORMED. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THAT THE DISTAL END UNIT, BIOPSY SUCTION CHANNEL, AIR/WATER CHANNEL, AND AUXILIARY WATER CHANNELS OF THE SCOPE WERE CULTURED, AND NO DETECTION OF BACTERIA WAS FOUND. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH-LEVEL DISINFECTION AND RINSED WITH STERILE WATER. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, ON (B)(6) 2023, THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. MICROBIOLOGICAL TESTS WERE PERFORMED IN THE OPERATIVE CHANNEL WITH GREATER THAN 300 COLONY-FORMING UNITS (CFUS); THE ASPIRATION CHANNEL WITH GREATER THAN 300 CFU¿S; AND THE AIR AND WATER CHANNELS WITH 2020 CFU OF PSEUDOMONAS AERUGINOSA. THE USER DID NOT REPORT ANY 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
    1208169 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown