BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 12689879 · Received October 25, 2021

    Report

    Report Number
    8010047-2021-13597
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 22, 2021
    Report Date
    March 30, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K202661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER PROVIDED CLEANING DISINFECTION AND SANITIZATION (CDS) PRACTICES, RESULTS OF THIRD PARTY TESTING, 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. 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 IS INCLUDED IN THE DEVICE IFU: "WARNING: 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

    A REVIEW OF THE CUSTOMER¿S CDS CHECKLIST SHOWED THAT THE SCOPE WAS LAST CULTURED ON (B)(6), 2021 FOLLOWING MAINTENANCE. THE CUSTOMER USES FRANKLAB DDN 9 NEUTRAL CLEANING DETERGENT FOR PRECLEANING AND AUTRE FOR DISINFECTANT. THE BIOPSY VALVE, AIR VALVE, AND SUCTION VALVE ARE DISINFECTED OR STERILIZED BY AUTOMATE. THE CUSTOMER USES A SOLUSCOPE 4 AUTOMATIC ENDOSCOPE PROCESSOR (AER) WITH SOLUSCOPE CLN DETERGENT AND SOLUSCOPE PAA DISINFECTANT. THE RETURNED DEVICE IS PENDING EVALUATION. THE DATE OF DEVICE RETURN IS UNKNOWN AT THIS TIME. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    OLYMPUS (OFR) WAS INFORMED BY THE USER FACILITY THAT AFTER A MICROBIOLOGICAL ROUTINE CONTROL ON THIS EVIS EXERA III DUODENOVIDEOSCOPE, THE USER FACILITY DETECTED AN UNEXPECTED CONTAMINATION. THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA AND STAPHYLOCOCCUS COAGULASE NEGATIVE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. THE SCOPE HAS BEEN RETURNED TO THE REGIONAL REPAIR CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587198 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown