BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 16310633 · Received February 7, 2023

    Report

    Report Number
    9610595-2023-01868
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 19, 2023
    Report Date
    April 27, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. 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, THE ROOT CAUSE OF THE FAILURE TO MAINTAIN THE DEVICE PROPERLY COULD NOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE : ¿¿CHAPTER 3 INSPECTION BEFORE USE, 3.9 INSPECTING THE DISINFECTANT SOLUTION¿S CONCENTRATION LEVEL¿ DESCRIBES THE FOLLOWING WARNING. BEFORE REPROCESSING THE ENDOSCOPE, BE SURE TO CHECK THAT THE DISINFECTANT SOLUTION HAS AN EFFECTIVE CONCENTRATION BY USING TEST STRIP. ALSO, BE SURE TO REPLACE THE DISINFECTANT SOLUTION BEFORE IT LOSES ITS EFFECTIVENESS. ALSO, THE METHODS FOR INSPECTING THE DISINFECTANT SOLUTION¿S CONCENTRATION LEVEL ARE DESCRIBED AS THE FOLLOWING. ·WHEN CHECKING THE CONCENTRATION OF THE DISINFECTANT SOLUTION BEFORE REPROCESSING. ·WHEN CHECKING THE CONCENTRATION OF THE DISINFECTANT SOLUTION DURING REPROCESSING. ·WHEN TEST STRIP IS USED TO CHECK THE CONCENTRATION OF DISINFECTANT SOLUTION. ·TAKING MEASURES WHEN RESTARTING REPROCESSING PROCESS IN THE CASE OF FAILURE TO CHECK THE EFFICACY OF THE DISINFECTANT SOLUTION¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    REPORTS ARE BEING SUBMITTED ON THE AERS AND SCOPES THAT WERE REPROCESSED. PLEASE REFER TO THE FOLLOWING REPORTS: PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: CF-H290I, SERIAL NUMBER: (B)(4). PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: OER-4, SERIAL NUMBER: (B)(4). PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: GIF-H290, SERIAL NUMBER: (B)(4). PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: GIF-Q260, SERIAL NUMBER: (B)(4). PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: OER-4, SERIAL NUMBER: (B)(4). THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN E99 ERROR MESSAGE OCCURRED ON AUTOMATIC ENDOSCOPE REPROCESSOR (AER) DURING MAINTENANCE ON JANUARY 12, 2022 AND THE ACESIDE CONCENTRATION HAD NOT BEEN CHECKED PREVIOUSLY. WHEN TROUBLESHOOTING WITH CUSTOMER SERVICE A WEEK LATER, THE CUSTOMER DISCOVERED THE CONCENTRATION OF THE ACESIDE WAS NOT CHECKED SINCE THE ERROR HAD OCCURRED. THE AER HAD BEEN USED TO REPROCESS THE EVIS LUCERA ELITE COLONOVIDEOSCOPE. THE NUMBER OF CASES WAS UNKNOWN. THE ACESIDE CONCENTRATION WAS THEN CHECKED TO CONFIRM THE CONCENTRATION WAS EFFECTIVE. CLEANING AND DISINFECTION WAS THEN CARRIED OUT. THE CUSTOMER WAS INSTRUCTED TO CHECK THE ACESIDE CONCENTRATION BEFORE CLEANING AND DISINFECTION EVERY TIME. THE CUSTOMER NOTED THE USUAL METHOD OF OPERATING ACESIDE AT THE FACILITY WAS TO REPLACE IT WHEN THE NUMBER OF DAYS USED AFTER PREPARATION EXCEEDED THE NUMBER OF DAYS USED BY THE FACILITY (ABOUT EVERY 14 DAYS OF OPERATION). THE ACESIDE HAD REACHED DAY 15 WHEN IT WAS USED WITHOUT CHECKING THE CONCENTRATION. THE CAUSE OF THE WHY THE CONCENTRATION WAS NOT CHECKED WAS UNKNOWN. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226160 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown