BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 20465062 · Received October 16, 2024

    Report

    Report Number
    9610595-2024-21181
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 4, 2024
    Report Date
    January 6, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 THERE WAS ZERO DETECTION OF ANY MICROBIAL GERMS. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S (LM) REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES, RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION AND THE LMS FINAL INVESTIGATION. THE LM REVIEWED THE CUSTOMER PROVIDED THE CDS PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: DISTAL END, BIOPSY CHANNEL, AIR/WATER CHANNEL, SUCTION CHANNEL (SWAB). CFU: N/A. BACTERIAL IDENTIFICATION: N/A. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: BIOPSY CHANNEL. CFU: <0.1 KBE/ML. BACTERIAL IDENTIFICATION: N/A. SAMPLING DATE: SEP 18, 2024. SAMPLING FROM: SUCTION CHANNEL. CFU: 100 KBE/ML. BACTERIAL IDENTIFICATION: KLEBSIELLA SPECIES, ENTEROBACTER CLOACAE, LECLERCIA ADECARBOXYLATA. 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, FOREIGN MATERIAL FOUND IN THE AIR/ WATER CYLINDER AND CHANNEL COULD NOT BE IDENTIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: 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 FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, ON (B)(6) 2024 THE COLONO VIDEOSCOPE TESTED POSITIVE FOR 0.2 COLONY FORMING UNITS (CFUS)/ML OF ENTEROBACTER CLOACAE. ON (B)(6) 2024 THE TEST WAS POSITIVE FOR 100 CFUS/ML OF KLEBSIELLA SPECIES, KLEBSIELLA OXYTOCA, ENTEROBACTER CLOACAE AND LECLERCCIA ADECARBOXYLATA. 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
    2571887 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown