BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 19805279 · Received July 23, 2024

    Report

    Report Number
    9610595-2024-14513
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 12, 2024
    Report Date
    November 1, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305214
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS FILE WAS ORIGINALLY SUBMITTED ON 7/19/2024 HOWEVER DUE TO THE CROWD STRIKE ERROR THE RECEIVING SERVER WAS DOWN, AND THIS FILE HAS NOW BEEN RESUBMITTED ON 7/23/2024.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H4: 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: ALL CHANNELS. CFU: 2 CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: MICROCOCCACEAE, ENTEROBACTER AEROGENES. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: BIOPSY CHANNEL. CFU: 1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: MICROCOCCACEAE. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SUCTION CHANNEL. CFU: <1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: CHAMPIGNONS FILAMENTEUX. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: AIR/WATER CHANNEL. CFU: <1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: N/A. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: AUXILIARY WATER CHANNEL. CFU: <1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: MICROCOCCACEAE. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: ALL CHANNELS. CFU: 3CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: UNKNOWN. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: BIOPSY CHANNEL. CFU: 1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: MICROCOCCACEAE. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SUCTION CHANNEL. CFU: 1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: AIR/WATER CHANNEL. CFU: 1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: N/A. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: AUXILIARY WATER CHANNEL. CFU: <1CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: N/A. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: ALL CHANNELS. CFU: 2CFU/ENDOSCOPE. BACTERIAL IDENTIFICATION: UNKNOWN. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE REPORTED EVENT. HOWEVER THERE WERE SCRATCHES NOTED IN THE BIOPSY CHANNEL, SUCTION CYLINDER, AND OTHER MINOR DAMAGE THAT MAY HAVE CONTRIBUTED TO THE CONTINUED CONTAMINATION. 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, ADDITIONAL MICROORGANISM TEST DETECTED THE SAME BACTERIA FROM THE SAME SAMPLING LOCATION AS THE 1ST MICROORGANISM TEST. THEREFORE, REPROCESSING MAY HAVE BEEN PERFORMED INSUFFICIENTLY. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "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, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR GREATER THAN 56 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS SPP AT 5 HOURS ON (B)(6) 2024, 59 CFUS PER ENDOSCOPE OF PSEUDOMONAS AERUGINOSA AND PSEUDOMONAS SPP AT 5 HOURS ON (B)(6) 2024, AND GREATER THAN 100 CFUS IN THE SUCTION CHANNEL OF PSEUDOMONAS AERUGINOSA AND PSEUDOMONAS SPP AT 5 HOURS ON (B)(6) 2024. 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 NEE A CONTRIBUTORY CAUSE.

    Description of Event or Problem · 0

    CORRECTION TO B5 OF THE INITIAL REPORT. THE USER PROVIDED THIRD-PARTY CULTURE RESULTS WERE AS FOLLOWS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SUCTION CHANNEL CFU: >56CFU/100ML . BACTERIAL IDENTIFICATION: PSEUDOMONAS SPP. SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: SUCTION CHANNEL CFU: 32CFU/100ML. BACTERIAL IDENTIFICATION: PSEUDOMONAS AERUGINOSA PSEUDOMONAS SPP. SAMPLING DATE: (B)(6) 2024 SAMPLING FROM: SUCTION CHANNEL CFU: >100CFU/ML. BACTERIAL IDENTIFICATION: PSEUDOMONAS AERUGINOSA PSEUDOMONAS SPP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964830 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190I 04953170305214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown