BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 19105187 · Received April 15, 2024

    Report

    Report Number
    9610595-2024-07846
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 3, 2024
    Report Date
    May 9, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170416118
    PMA / PMN Number
    K192793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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, THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE CLEANING DISINFECTION AND STERILIZATION PRACTICES (CDS) OF THE USER WERE REVIEWED. AND THERE WERE NO REPORTED DEVIATIONS, FROM THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS EVALUATED. AND THERE WERE NO ABNORMALITIES 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, IT IS LIKELY, THE USER¿S UNDERSTANDING ON DEVICE HANDLING DIFFERED FROM OLYMPUS RECOMMENDATIONS. AS THE DEVICE WAS USED ON PATIENTS, AFTER SAMPLING AND WAS NOT ISOLATED. 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: "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 DEVICE EVALUATION IS ONGOING. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND ONE (1) CFU OF STREPTOCOCCUS SALIVARIUS WAS FOUND IN THE INSTRUMENT/BIOPSY CHANNEL. THE DEVICE WAS RETESTED, AND NO MICRO-ORGANISMS WERE DETECTED. THE RESULTS ARE EVALUATED IN ACCORDANCE WITH THE JOINT RECOMMENDATION OF THE KRINKO AND THE BFARM 'REQUIREMENTS FOR HYGIENE IN THE REPROCESSING OF MEDICAL DEVICES' (BUNDESGESUNDHEITSBL 2012 - 55:). 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 HAVING USED THE COLONOVIDEOSCOPE ON A PATIENT WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. THE FORCEPS ELEVATOR CHANNEL FROM THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 17 COLONY FORMING UNITS (CFUS) OF PROVIDENCIA STUARTII. ALL CHANNELS WERE SAMPLED. 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
    1508216 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190L 04953170416118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown