BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 18351016 · Received December 18, 2023

    Report

    Report Number
    9610595-2023-19796
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 25, 2023
    Report Date
    January 12, 2024
    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 AND TO CORRECT B5 AND H10 WITH ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER THAT WAS INADVERTENTLY MISSED ON THE INITIAL MEDWATCH. CORRECTION TO H10: THE FACILITY REPROCESSES USING A NON-OLYMPUS PRODUCT (BY KAIGEN PHARMA CO., LTD), A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE FOREIGN MATERIAL FOUND CONTAINED AMORPHAS CARBON (SPHERICAL IN SHAPE), POLYPROPYLENE (WHITE SOLID MATERIAL), AND CELLULOSE FIBER (A WHITE FIBER). HOWEVER, THE CAUSE OF THE FOREIGN MATERIAL REMAINING ON THE DEVICE COULD NOT BE CONCLUSIVELY ESTABLISHED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE: REPROCESSING MANUAL CHAPTER 5 ¿REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)¿. SECTION 5.5 ¿MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES¿ UNDER CLEAN THE EXTERNAL SURFACE, DESCRIBES HOW TO CLEAN THE ENDOSCOPE DESCRIBES HOW TO CLEAN THE DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS CLEANED, DISINFECTED, AND STERILIZED BEFORE IT WAS SENT IN FOR REPAIR. THE DEVICE WAS CLEANED, DISINFECTED, AND STERILIZED THE PRODUCT BEFORE IT WAS SENT IN FOR REPAIR. ACCORDING TO THE CUSTOMER, IT WAS UNKNOWN WHEN THE FOREIGN MATERIAL ADHERED TO THE AIR/WATER NOZZLE, THERE WAS NO DELAY IN THE START OF THE PRE-CLEANING, THE AIR/WATER NOZZLE WAS FLUSHED WITH AIR AND WATER, THE NOZZLE WAS CLEANED WITH LINT-FREE CLOTHS/BRUSHES/SPONGES AND, THE AIR/WATER NOZZLE WAS FLUSHED WITH DETERGENT SOLUTION. THERE WERE NO ABNORMALITIES IN THE ACCESSORIES USED FOR REPROCESSING. THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER'S ALLEGATION HAS BEEN CONFIRMED. IN ADDITION TO THE MALFUNCTION DOCUMENTED IN B5, THE ADDITIONAL EVALUATION FINDING FOUND CORROSION ON THE ELECTRICAL CONTACTS OF THE SCOPE CONNECTOR. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE INTENDED PROCEDURE WAS DIAGNOSTIC AND THERE WAS AN APPROXIMATELY 5 MINUTE DELAY IN THE PROCEDURE FOR EQUIPMENT REPLACEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE COLONOVIDEOSCOPE, FOR A COLONOSCOPY PROCEDURE THERE WAS DIFFICULTY INSERTING THE SCOPE AND THE ANGLE WIRE BROKE. THE CUSTOMER FURTHER REPORTED THERE WERE NO PROBLEMS WITH THE UNIT DURING PRE-INSPECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER SCOPE AT THE FACILITY. THERE WERE NO DELAYS OR PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION FOREIGN MATTER INSIDE THE NOZZLE WAS FOUND. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718904 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown