BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 13596485 · Received February 24, 2022

    Report

    Report Number
    8010047-2022-03551
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Report Date
    April 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE INSPECTION AND EVALUATION FOUND THE NOZZLE CLOGGED WITH FOREIGN MATERIAL. A PLASTIC MATERIAL FOUND PROTRUDING FROM THE NOZZLE. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. SERVICE REPAIR NOTED THAT DUE TO CLOGGING OF NOZZLE, AIR SUPPLY VOLUME DOES NOT MEET THE STANDARD VALUE. FURTHERMORE, THE FOLLOWING FINDINGS DURING DEVICE INSPECTION WERE NOTED : DUE TO A CUT ON HEAT SHRINKING TUBE OF FE LEVER, EXPECTED INSULATION CAPACITY CANNOT BE OBTAINED. BENDING TUBE IS DAMAGED, CONNECTING TUBE , UNIVERSAL, SWITCH BOX, S-COVER, RIGHT/LEFT KNOB HAS SCRATCH. DUE TO WEAR OF ANGLE WIRE, THE PLAY OF U/D KNOB IS OUT OF THE STANDARD VALUE. LIGHT GUIDE LENS HAS CRACK , COLOR RING HAS CRACK AND GRIP IS STICKY. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL 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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE FOLLOWING WERE THE PRESUMED CAUSES OF THE SUGGESTED PHENOMENON: A) THE BRUSH WAS BROKEN DURING BRUSHING OF THE AIR/WATER VALVE. THEN BRISTLE ENTERED THE AIR/WATER CHANNEL AND STUCK IN THE NOZZLE. B) FOR REPROCESSING, USER HAD USED A CLOTH SUCH AS GAUZE IN WHICH LINT COMES OFF. THEN LINT LODGED INTO THE AIR/WATER CHANNEL AND MADE THE NOZZLE CLOG. THE USER CAN PROPERLY DETECT THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU) OPERATION MANUAL STATEMENT: "INSPECT THE AIR/WATER NOZZLE AT THE DISTAL END OF THE ENDOSCOPE¿S INSERTION SECTION FOR ABNORMAL SWELLING, BULGES, DENTS, OR OTHER IRREGULARITIES" IT IS POSSIBLE THAT THE USER CAN REDUCE/PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU REPROCESSING MANUAL STATEMENT: "ALL CLOTHS USED IN REPROCESSING ARE RECOMMENDED TO BE LINT-FREE. LINT OR CLOTH FIBERS SHED INTO REPROCESSING FLUIDS MAY BE INJECTED INTO THE ENDOSCOPE CHANNELS. THERE IS THE POTENTIAL FOR LINT OR CLOTH FIBERS TO LODGE IN CHANNELS OR BECOME TRAPPED IN THE AIR/WATER NOZZLE. IF GAUZE IS USED TO REPROCESS THE ENDOSCOPE, ENSURE THAT FIBERS DO NOT GET CAUGHT ON OR REMAIN TRAPPED BY PROTRUDING COMPONENTS LIKE THE AIR/WATER NOZZLE." ON MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES, THE IFU STATES THE FOLLOWING: "THOROUGHLY BRUSH OR WIPE ALL EXTERNAL SURFACES OF THE ENDOSCOPE, USING CLEAN LINT-FREE CLOTHS, BRUSHES, OR SPONGES. PAY PARTICULAR ATTENTION TO THE AIR/WATER NOZZLE OPENING AND THE OBJECTIVE LENS ON THE DISTAL END OF THE INSERTION SECTION, AND CONFIRM THAT ALL DEBRIS IS REMOVED FROM ALL SURFACES OF THE DISTAL END." THE IFU CONTINUES ON THE SUBJECT OF THE CHANNEL CLEANING BRUSH: - "INSPECTION: CHECK THE BRISTLES FOR DAMAGE. IF THE BRISTLES ARE CRUSHED, GENTLY STRAIGHTEN THEM WITH YOUR GLOVED FINGERTIPS." - "THE CHANNEL CLEANING BRUSH (BW-20T) IS CONSUMABLE. THE SINGLE USE COMBINATION CLEANING BRUSH (BW-412T) IS FOR SINGLE USE. REPEATED USAGE OF THESE BRUSHES MAY CAUSE THE BRUSH HEAD TO BECOME BENT OR KINKED, WHICH COULD CAUSE IT TO COME OFF DURING USE. CONFIRM THAT THE BRUSH IS FREE FROM ANY DAMAGE OR OTHER IRREGULARITIES BEFORE AND AFTER USE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER SENT A REPAIR REQUEST FOR " FAILED FLUSHING PRESENTING CHANNEL 4 OBSTRUCTED" . THE ISSUE FOUND DURING REPROCESSING. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND FOREIGN MATERIAL LODGED AT THE NOZZLE UNIT. THIS REPORT IS BEING SUBMITTED FOR FOREIGN MATERIAL FOUND ON DEVICE NOZZLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437033 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H185L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown