BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 20976033 · Received December 19, 2024

    Report

    Report Number
    9610595-2024-40639
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 13, 2024
    Report Date
    March 24, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL 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 EVENT WAS REPORTED IS A DUPLICATE REPORT. PLEASE REFER TO MFG REPORT # 9610595-2024-40535-00.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION. THE COMPLAINT INVESTIGATION REVIEWED THE CUSTOMER PROVIDED THE CDS PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. THE USER FACILITY PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SUCTION CHANNEL. CFU: <1CFU. BACTERIAL IDENTIFICATION: ENTEROBACTER CLOACAE COMPLEX 3 COLONIES. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE REPORTED EVENT. 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 THE IFU BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCOPE TESTED POSITIVE FOR 3 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX IN THE CHANNELS ON 11/13/2024. ON 11/18/2024 THE SCOPE TESTING SHOWED 2 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX. 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 THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCOPE TESTED POSITIVE FOR 3 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX IN THE CHANNELS ON (B)(6) 2024. ON (B)(6) 2024 THE SCOPE TESTING SHOWED 2 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX. 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
    2099063 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-PQ260L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown