BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 16643565 · Received March 30, 2023

    Report

    Report Number
    9610595-2023-05286
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 8, 2023
    Report Date
    June 22, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED DETAILS ON THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) PROCESS FOLLOWED ONSITE. THE PRE-CLEANING AND MANUAL CLEANING DETERGENT USED WAS ANIOS CLEAN EXCEL D. THE CUSTOMER ASPIRATES WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL. DURING MANUAL CLEANING, THE CUSTOMER BRUSHES THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, BALLOON CHANNEL AND DISTAL END/AREAS AROUND ELEVATOR USING THE BRUSH ASEPT IN MED (REFERENCE:201664). THE SCOPE WAS MANUALLY DISINFECTED USING ANIOS CLEAN EXCEL D. THE CUSTOMER USES AUTOMATED ENDOSCOPIC REPROCESSOR SOLUSCOPE ALONG WITH DETERGENT CLN AND DISINFECTANT PERACETIC ACID (PAA). THE AER WAS CULTURED; HOWEVER, RESULTS WERE NOT PROVIDED. THE ENDOSCOPE WAS STORED IN A DRYING CABINET (MODEL:ETD SYSTEM) AND WAS VERTICALLY HANGED. THE ENDOSCOPE WAS NOT STERILIZED. THE DEVICE WAS RETURNED. THE PHYSICAL DEVICE EVALUATION HAS NOT YET BEEN COMPLETED; 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 REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION REGARDING OLYMPUS HMI RESULTS AND DEVICE EVALUATION FINDINGS. THE DEVICE WAS RETURNED. PRIOR TO THE DEVICE EVALUATION, THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. THE DEVICE TESTED POSITIVE FOR LESS THAN ONE (1) COLONY FORMING UNITS OF REVIVABLE MICROORGANISM. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE RETURNED DEVICE WAS EVALUATED. THE CONTROL UNIT EXHIBITED WATER LEAKAGE. THE INSULATION OF THE DISTAL END WAS LESS THAN THE THRESHOLD VALUE. THE ADHESIVE OF THE DISTAL END AND CHARGE COUPLED DEVICE (CCD) COVER LENS WAS CHIPPED. THE ADHESIVE OF THE BENDING SECTION COVER WAS SEPARATED AND DISCOLORED. THE CONNECTING TUBE WAS WRINKLED. THE UNIVERSAL CORD HAD BUCKLING. THE PLUG UNIT HOUSING WAS DAMAGED. THE ANGULATION IN ALL DIRECTIONS WAS LESS THAN THE SPECIFIED VALUE AND ANGLE KNOBS EXHIBITED PLAY. THE BIOPSY CHANNEL HAD WEAR AND TEAR. THE INVESTIGATION IS ONGOING. 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. THE REPROCESSING STEPS PROVIDED BY THE USER WERE REVIEWED WHERE THE FOLLOWING DEVIATION FROM INSTRUCTIONS FOR USE (IFU) WAS CONFIRMED: - FLUSHING WAS NOT PERFORMED FOR AIR/WATER CHANNEL NOR AUXILIARY WATER CHANNEL AT PRECLEANING. 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 DEVIATION FROM IFU WAS CONFIRMED THEREFORE, REPROCESSING MAY HAVE BEEN CONDUCTED INSUFFICIENTLY. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH 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." "FLUSH THE AIR/WATER CHANNEL WITH WATER AND AIR: TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE." "FLUSH THE AUXILIARY WATER CHANNEL: THE AUXILIARY WATER CHANNEL MUST BE FLUSHED EITHER MANUALLY OR USING AN OLYMPUS FLUSHING PUMP (ENDOSCOPIC FLUSHING PUMP OFP OR OFP-2)." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT FROM THE CUSTOMER INDICATED THAT ALL CHANNELS OF THE SCOPE WERE CULTURED. THE CHANNELS TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE MICROBIOLOGICAL QUALITY OF THE ENDOSCOPE WAS NOT SATISFACTORY, FOR THE PARAMETERS SOUGHT, FOR AN ENDOSCOPE SUBJECTED TO INTERMEDIATE LEVEL DISINFECTION AND RINSED WITH BACTERIOLOGICALLY CONTROLLED WATER. 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
    210343 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown