BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 21901611 · Received April 24, 2025

    Report

    Report Number
    9610595-2025-06958
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Report Date
    July 1, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K192793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON CUSTOMER ADDITIONAL INFORMATION (B5) AND THE FINAL INVESTIGATION. THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WERE NOT SHARED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, THE SUBJECT DEVICE TESTED POSITIVE FOR 32 COLONY-FORMING UNITS PER GRAM (KBE) OF AEROB-MESOPHILE. 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.

    Description of Event or Problem · 0

    THE DEVICE WAS MACHINE-PROCESSED BY THE ENDOTHERMO DISINFECTORS (ETD4) REPROCESSER, SAMPLED AND WAS FOUND TO COMPLY WITH THE STANDARD. ACCORDING TO THE "SWISS GUIDELINE FOR THE REPROCESSING OF ENDOSCOPES," THE CUSTOMER MAY REPROCESS AND SAMPLE THEIR DEVICE AGAIN AND DOES NOT HAVE TO RETURN IT TO OLYMPUS FOR FURTHER CULTURE TESTING. THE PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290258 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENDOTHERMO DISINFECTORS ETD4 - OLYMPUS MEDICAL SYS