BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15828413 · Received November 18, 2022

    Report

    Report Number
    9610595-2022-04274
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 24, 2022
    Report Date
    January 3, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS AND WAS INSPECTED FOR DEFECTS. THERE WERE NO FINDINGS. PRIOR TO THE DEVICE EVALUATION, THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. THE DISTAL END UNIT, THE BIOPSY/INSTRUMENT/SUCTION CHANNEL, AIR/WATER CHANNEL AND AUXILIARY WATER CHANNEL WERE CULTURED AND THERE WAS NO DETECTION OF ANY BACTERIAL GROWTH. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION REGARDING THE CLEANING, DISINFECTION AND STERILIZATION (CDS) PROCESSES PERFORMED ONSITE. DURING PRE-CLEANING, THE CUSTOMER ASPIRATES WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AND FLUSHES OUT THE AIR/WATER, AUXILIARY, BALLOON AND FORCEPS ELEVATOR WIRE CHANNEL. DURING MANUAL CLEANING, THE CUSTOMER USES BODEDEX DETERGENT AND BRUSHES INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, DISTAL END AND AREAS AROUND ELEVATOR USING DISPOSABLE BRUSH FROM OLYMPUS. THE AUTOMATED ENDOSCOPIC REPROCESSOR (AER) MODEL USED WAS GETINGE 2H110180.THE DETERGENT SOLUTION AND DISINFECTANT USED FOR AER WAS GETINGE DLC/POKA-YOKE DLC AND GETINGE APERLAN POKA-YOKE AGENT A OG B. THE ENDOSCOPES ARE STORED IN A DRYING CABINET (MODEL: GETINGE FD8 6MO12633) AND OLYMPUS IS THE MAINTENANCE COMPANY THE USER FACILITY USES. THE INVESTIGATION IS ONGOING AND A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS AVAILABLE.

    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 AND BECAUSE THE USER CULTURE RESULTS WERE NOT SHARED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL VIDEOSCOPE REPEATEDLY TESTED POSITIVE FOR BACTERIAL GROWTH IN WORKING CHANNEL. THE ISSUE WAS FOUND DURING A 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
    237392 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown