BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 17741741 · Received September 13, 2023

    Report

    Report Number
    9610595-2023-13322
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 9, 2023
    Report Date
    October 13, 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

    CUSTOMER PROVIDED THE HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS AND NOTED AS FOLLOW: FINAL SAMPLING DATE REPORT : (B)(6) 2023 AFTER HIGH LEVEL DISINFECTANT AND STERILE WATER RINSE . THE RESULTS REPORTED THE DEVICE (ALL CHANNELS) WERE TESTED AND TESTED POSITIVE WITH THE FOLLOWING: ENTEROBACTER <14 CFU/100ML PSEUDOMONAS AERUGINOSA SAMPLING REPORT (B)(6) 2023 - >73 CFU/100 ML ( AEROBIC MICROORGANISM, ENTEROBACTER, PSEUDOMONAS AERUGINOSA, PSEUDOMONAS SPP). SAMPLING REPORT (B)(6) 2023 - >100 CFU/ENDOSCOPE (AEROBIC MICROORGANISM), >72 CFU/100 ML (AEROBIC MICROORGANISM). THE OLYMPUS FRANCE FRENCH OLYMPUS SUBSIDIARY FOR HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED. THE RESULTS REPORTED DEVICE CHANNEL (ALL CHANNELS) CONFORMS TO RESULTS OF <1 CFU/100 ML AND <1 CFU/ENDOSCOPE (MICROORGANISM REVIVABLE) . THE RESULTS <1 OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE REGULATIONS OF FRANCE OUTLINED ON JULY 4, 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. THE CUSTOMER PROVIDED THE CLEANING, STERILIZATION, AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. THE CDS FORM NOTED THAT THERE WERE NO DEVIATIONS OR DEFICIENCIES CONCERNING THE REPROCESSING OF THE SCOPE. ADDITIONALLY, IT WAS NOTED THAT THERE IS NO SUSPECTED PATIENT INFECTION. CDS NOTED MANUAL AND PRECLEANING WAS PERFORMED ON THE DEVICE IMMEDIATELY AFTER PATIENT PROCEDURE, ALL CHANNELS WERE BRUSHED, DISTAL END FLUSHED USING DISTAL END ADAPTER ALONG WITH FORCEPS ELEVATOR (DETERGENT USED IS FRANKLAB). REPROCESSOR IS A SOLUSCOPE (DETERGENT/DISINFECTANT USED IS ALSO SOLUSCOPE. WATER QUALITY WAS CONTROLLED AND WATER FILTER REPLACED IN ACCORDANCE WITH IFU. DEVICE WAS DRIED USING FILTERED COMPRESSED AIR. STORED IN SIMPLE CABINET. DEVICE WAS REPROCESSED TWICE AND LAST REPROCESSED ON (B)(6) 2023. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING THE INVESTIGATION.

    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 DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. THE FOLLOWING DEFECTS WERE NOTED: - DISTAL END CAP COVER --- INSULATION < THRESHOLD. - BENDING SECTION RUBBER GLUE --- SEPARATED. - CONNECTING TUBE --- WRINKLE 10MM FROM GLUE. - SPECIFIED ANGLE AND ORIENTATION ACHIEVED FAILED. 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 THE INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE CUSTOMER THEN LEFT THE DEVICE TO THE OLYMPUS FRANCE (OFR) FRENCH OLYMPUS SUBSIDIARY FOR HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) FOR FURTHER INVESTIGATION. NO REPORT OF ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396718 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown