BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 21307568 · Received February 4, 2025

    Report

    Report Number
    9610595-2025-01117
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 23, 2025
    Report Date
    November 5, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5. CORRECTION: B3, D1, D4. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT IS RELATED TO MFRS 05268 (2/3), MFR 05266 (3/3).

    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 A CORRECTION TO A PREVIOUSLY SUBMITTED REPORT. THIS WAS REPORTED IN ERROR WITH AN INCORRECT SERIAL NUMBER FOR THE SUBJECT DEVICE. THERE IS NO ALLEGATION OF A POSITIVE MICROBIOLOGICAL TEST FOR THIS DEVICE CF-H190L, SERIAL NUMBER: (B)(6) . REFER TO REPORTS MFG# 9610595-2025-05268 AND MFG# 9610595-2025-05266 FOR THE DEVICE INVOLVED IN THIS EVENT CF-EZ1500DL, SERIAL NUMBER: (B)(6) .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE WAS TESTED TWICE AND RECEIVED TWO POSITIVE MICRO TESTS. THE FIRST TEST FOUND A MIXTURE OF SMALL ORGANISMS. THE SMALL ORGANISMS WERE MORE THAN 100 COLONY FORMING UNITS (CFUS) OF MORAXELLA OSLOENSIS, NEISSERIA FLAVESCENS, MICROCOCCUS LUTEUS, AND STAPHYLOCOCCUS HAEMOLYTICUS. THE SECOND TEST SHOWED ECOLI PRESENT. ALL CHANNELS WERE SAMPLED. THE ISSUE WAS FOUND DURING REPROCESSING. DURING FOLLOW-UP WITH THE USER FACILITY, IT WAS NOTED THAT THE SUBJECT DEVICE WAS USED ON 2 PATIENTS WHILE AWAITING THE POSITIVE CULTURE RESULTS. 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

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE WAS TESTED TWICE AND RECEIVED TWO POSITIVE MICRO TESTS. THE FIRST TEST FOUND SMALL ORGANISMS AND THE SECOND TEST SHOWED ECOLI PRESENT. THE ISSUE WAS FOUND DURING REPROCESSING. 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

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48338 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown