BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 16382869 · Received February 15, 2023

    Report

    Report Number
    9610595-2023-02608
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Report Date
    April 28, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305153
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. ALL CHANNELS WERE SAMPLED. THE DEVICE TESTED POSITIVE FOR LESS THAN ONE (1) COLONY FORMING UNIT OF UNSPECIFIED MICRO-ORGANISMS. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE USER FACILITY PROVIDED ADDITIONAL INFORMATION REGARDING THE CLEANING, THE DISINFECTION AND THE STERILIZATION PROCESSES PERFORMED ONSITE FOR THE ENDOSCOPES. DURING PRE-CLEANING, THE CUSTOMER USES DDN 9 FRANKLAB DETERGENT, SUCTIONS WATER OUT OF THE CHANNELS AND FLUSHES OUT THE AIR/WATER, AND AUXILIARY WASHING CHANNEL. THE CUSTOMER REPORTED THAT NO MANUALLY DISINFECTION OF THE SCOPES WAS PERFORMED. FOR AUTOMATED ENDOSCOPE REPROCESSOR (AER) TREATMENT, THE SOLUSCOPE 4 WASHER ALONG WITH SOLUSCOPE CLN DETERGENT AND SOLUSCOPE PAA DISINFECTANT WAS USED. THE SCOPE WAS STORED IN A SOLUSCOPE DSC8000 DRYING CABINET AND OLYMPUS IS THE CUSTOMER¿S MAINTENANCE COMPANY. THE SCOPE WAS NOT STERILIZED. THE DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION IS CURRENTLY IN PROCESS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED TO PROVIDE CORRECTION TO THE INDEPENDENT LABORATORY TEST RESULTS. THE CORRECT RESULT FROM THE LAB TESTING IS BELOW. THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. ALL CHANNELS WERE SAMPLED. THE DEVICE TESTED POSITIVE FOR ONE (1) COLONY FORMING UNIT OF COAGULASE-NEGATIVE STAPHYLOCOCCI. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIRE TARGET LEVELS ESTABLISHED BY THE FRENCH REGULATION OF JULY 4, 2016.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE REPROCESSING STEPS PROVIDED BY THE USER WERE REVIEWED WHERE THE FOLLOWING DEVIATION FROM INSTRUCTIONS FOR USE (IFU): - BRUSHING WAS NOT PERFORMED FOR BIOPSY CHANNEL, SUCTION CHANNEL, BIOPSY PORT, OR SUCTION CYLINDER AT MANUAL CLEANING. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. THE FOLLOWING DEFECTS WERE NOTED: - ELECTRICAL SAFETY CHECKS BY USING EMT / MPE TESTER FAILED - DISTAL END --- LIGHT GUIDE ROD LENS (3X) --- CRACKED - CHARGED COUPLED DEVICE COVER LENS --- CRACKED - DISTAL END CAP COVER -- - SCRATCH - BENDING SECTION RUBBER GLUE --- SEPARATED - CONNECTING TUBE --- SNAKINESS - CONNECTING TUBE --- WRINKLE - SCOPE BODY --- DAMAGED - SCOPE COVER --- CRACKED - KEY TOP 1 --- UNCLEAR INDICATION - SWITCH BOX UNIT --- SCRATCHED - UNIVERSAL CORD --- BUCKLES - AIR/WATER, SUCTION, GROUND, AUXILIARY CHANNEL CONDITION OF PORTS FAILED CONNECTOR --- SCOPE CONNECTOR COVER --- DETACHED: - INSERTION PART --- BENDING TUBE --- MOVEMENT - SUCTION FUNCTION 26,7KPA SPECIFY SUCTION FLOW (ML/MIN) FAILED HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE 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, THE POSSIBILITY OF INSUFFICIENT REPROCESSING DUE TO DEVIATION FROM IFU CAN NOT BE DENIED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: CHAPTER "REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)" / "MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES"/ "BRUSH THE CHANNELS" "BE SURE TO THOROUGHLY BRUSH THE INSIDE OF THE INSTRUMENT CHANNEL, THE INSTRUMENT CHANNEL PORT, THE SUCTION CHANNEL, AND THE SUCTION CYLINDER OF THE ENDOSCOPE. INSUFFICIENT BRUSHING MAY POSE AN INFECTION CONTROL RISK." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR GREATER THAN 100 COLONY FORMING UNIT (CFU) OF STENOTROPHOMONAS MALTOPHILIA AND 9 COLONY FORMING UNIT (CFU) OF BURKHOLDERIA CEPACIA. ALL CHANNELS WERE SAMPLED. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. SAMPLING WAS TAKEN AT REPROCESSING, BEFORE USE. 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
    943916 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H190L 04953170305153

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown