BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 20258301 · Received September 19, 2024

    Report

    Report Number
    9610595-2024-18780
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 8, 2024
    Report Date
    November 19, 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
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION AND BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE EVENT DATE WAS CORRECTED FROM AUG 27, 2024, TO AUG 8, 2024. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES (LM) AND LMS FINAL INVESTIGATION. SINCE THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN, THE DEVICE HISTORY REVIEW COULD NOT BE INVESTIGATED. IN ADDITION, NO INFORMATION ON THE REPROCESSING PROCEDURE WAS OBTAINED FROM THE USER. IT IS IMPOSSIBLE TO DENY THE POSSIBILITY THAT THE REPROCESSING WAS INSUFFICIENT. THE REPORTED EVENT WAS NOT CONFIRMED AS THE SCOPE WAS NOT MICROBIOLOGICALLY TESTED BY OLYMPUS. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE RELEVANCE BETWEEN THE DEVICE AND THE DETECTION OF BACTERIA COULD NOT BE ESTABLISHED AND A ROOT CAUSE COULD NOT BE DETERMINED. THE IFU WARNS AGAINST IMPROPER REPROCESSING OF ENDOSCOPES AND ACCESSORIES, STATING, ¿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 THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOCOPE TESTED POSITIVE FOR > 1000 COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS SPECIES (KNS) AND 30 CFU OF STAPHYLOCOCCUS AUREUS ON AUGUST 8TH, 2024. THE SCOPE WAS RETESTED ON AUGUST 14, 2024 FOR 200 POSITIVE CFUS OF ESCHERICHIA COLI. THE SCOPE WENT FOR FINAL TESTING ON AUGUST 20TH, 2024 FOR 24 CFUS OF STAPHYLOCOCCUS SPECIES (KNS), 4 CFU OF BACILLUS SPECIES. 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
    1530604 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190L 04953170416118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown