BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 16100052 · Received January 4, 2023

    Report

    Report Number
    9610595-2023-00185
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Report Date
    March 7, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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, THE ROOT CAUSE COULD NOT BE DETERMINED. EVENT 1: FOREIGN MATERIAL CLOGGED IN THE NOZZLE. IT IS LIKELY THAT THE FOREIGN MATERIAL, WHICH WAS LARGER THAN THE INNER DIAMETER OF THE AIR/WATER NOZZLE, HAD ENTERED INSIDE THE AIR/WATER CHANNEL AND RESULTED IN THE CLOG. THE CAUSE OF THE MATERIAL ENTERING THE CHANNEL COULD NOT BE SPECIFIED. THE NOZZLE WAS NOT REPORTED TO HAVE BEEN DEFORMED. AN ATTEMPT WAS MADE TO OBTAIN THE USER'S REPROCESSING METHODS BUT THE ONLY INFORMATION PROVIDED WAS THAT THEY USE A KOKEN CO., LTD. WASHING MACHINE AND THE ISSUE WAS LIKELY CAUSED BY ELECTROLYZED WATER. NO FURTHER INFORMATION WAS PROVIDED. EVENT 2: FOREIGN MATERIAL ADHERED TO THE PLASTIC DISTAL END COVER (C-COVER). THE SPECIFIC MATERIAL COULD NOT BE IDENTIFIED AND THE CAUSE COULD NOT BE CONCLUSIVELY SPECIFIED BUT IS LIKELY FOREIGN MATERIAL ADHERED TO THE C-COVER DUE TO INSUFFICIENT REPROCESSING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. THERE WAS DAMAGED TO THE UP/DOWN KNOB THAT HAD CAUSED THE SOUND. IN ADDITION TO THE FINDINGS REPORTED, SCRATCHES, CORROSION AND CRACKS WERE FOUND ON PARTS OF THE DEVICE. THE WORN ANGLE WIRE CAUSED THE PLAY OF THE UP/DOWN KNOB AND THE BENDING ANGLE IN THE UP DIRECTION TO NOT MEET SPECIFICATION. THE ADHESIVE ON THE BENDING SECTION COVER WAS CHIPPED, CRACKED AND HAD A WHITE CLOUDED AREA. THE FORCEPS CHANNEL HAD A PINHOLE, PART OF THE INSERTION TUBE WAS DEFORMED, THE ADHESIVE AROUND THE OBJECTIVE LENS WAS PEELED (CAUSING FLARING), THE MOUTHPIECE WAS LOOSE AND THE INSERTION SECTION WAS STIFF DUE TO A DAMAGED FLEXIBILITY ADJUSTMENT RING. THE CONNECTING TUBE WAS WRINKLED AND THE SUCTION TUBE FROM THE UNIVERSAL CORD WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS AN ABNORMAL NOISE DURING ANGULATION WHEN USING THE EVIS LUCERA COLONOVIDEOSCOPE. DURING INSPECTION AND TESTING OF THE RETURNED DEVICE, DEBRIS WAS FOUND ADHERING TO THE DISTAL END COVER AND CLOGGING THE NOZZLE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900464 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-Q260AI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown