BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 15825597 · Received November 18, 2022

    Report

    Report Number
    9610595-2022-04229
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 24, 2022
    Report Date
    February 24, 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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION.PATIENT INFORMATION, INCLUDING PRE-EXISTING MEDICAL CONDITIONS, IS NOT KNOWN. DEVICES USED IN CONJUNCTION WITH THE DEVICE AT THE TIME OF THE EVENT ARE NOT KNOWN. INFORMATION OF REPROCESSING PERFORMED AT THE FACILITY: AN AIR WATER CHANNEL CLEANING ADAPTER IS USED FOR PRE-CLEANING WHICH IS PERFORMED IMMEDIATELY AFTER A PROCEDURE. THE STEPS TAKEN DURING THE PRE-CLEANING ARE: APPROXIMATELY 30 SECONDS OF WATER DELIVERY AND 10 SECONDS OF AIR DELIVERY. DETERGENT USED FOR PRE-CLEANING IS ENDOFRESH A. MANUAL CLEANING IS PERFORMED WITHIN AN HOUR AFTER THE PROCEDURE. THE ENDOSCOPE CHANNELS ARE BRUSHED DURING MANUAL CLEANING WITH A REUSABLE BRUSH OF UNKNOWN MODEL NUMBER. CLEANING AND DISINFECTANT SOLUTIONS USED WITH THE ENDOSCOPE IS DISOPA THE DEVICE IS APPROPRIATELY RINSED BEFORE MANUAL DISINFECTION. ALL CHANNELS ARE FLUSHED WITH AND IMMERSED IN THE DISINFECTANT. IT IS NOT KNOWN IF THE WATER QUALITY IS CHECKED IN THE FINAL RINSE. AUTOMATIC ENDOSCOPY REPROCESSOR (AER) BEING USED TO REPROCESS THE ENDOSCOPE ASP ENDOCLEANSE DETERGENT AND DISINFECTANT USED WITH THE AER ARE NOT KNOWN. IT IS NOT KNOWN IF THERE HAVE BEEN ANY ISSUES WITH THE AER. HOW THE DEVICE IS DRIED AFTER REPROCESSING IS NOT KNOWN. DEVICE IS STORED IN A VAULT.

    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. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS CONFIRMED AS FOREIGN MATERIAL IN THE NOZZLE, BUT IT COULD NOT BE FURTHER IDENTIFIED. AS THERE WAS NO APPARENT DEVIATION OF REPROCESSING OF THE DEVICE, A FURTHER CAUSE OF THE SUGGESTED PHENOMENON COULD NOT BE PRESUMED. AS A PREVENTIVE MEASURE, IT IS SUGGESTED THAT THE USER FACILITY REVIEW THE METHOD OF REPROCESSING FOR THE DEVICE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS RETURNED, AND AN EVALUATION COMPLETED FOR IT. UPON INSPECTION AND TESTING, IT WAS OBSERVED THAT THERE IS PRESENCE OF FOREIGN MATERIAL CLOGGING THE NOZZLE. THIS IS ATTRIBUTED TO INSUFFICIENT CLEANING. DUE TO THE CLOGGING OF THE NOZZLE, THE DRAINING FUNCTION IS REDUCED. OTHER OBSERVATIONS FOR THE DEVICE ARE: NOISE OCCURS IN THE IMAGE DURING UP/DOWN (U/D)D DIRECTION ANGLE OPERATION; DISCOLORATION OF THE OBJECTIVE LENS DUE TO HANDLING; CLOUDINESS OF THE IMAGE; BENDING ANGLE IS INSUFFICIENT AND PLAY OF THE ANGLE KNOB IS OUT OF STANDARD DUE TO STRETCHING OF THE ANGLE WIRE; DISTAL END RUBBER COATING (A-RUBBER) ADHESIVE IS MISSING; WATER INVASION OBSERVED IN THE ELECTRIC CONNECTOR; DISCOLORATION OF THE OPERATION PART; SUCTION CYLINDER IS SCRAPED; AND SCRATCHES ARE FOUND ON THE INSERTION TUBE, OPERATION PART, OPERATION UNIT, U/D KNOB AND ANGLE FIXING LEVER, RIGHT/LEFT KNOB AND ANGLE FIXING LEVER, GRIP, UNIVERSAL CORD, SCOPE CONNECTOR, AND SCOPE CONNECTOR JOINT CASE. THE USER¿S COMPLAINT OF NOISE IN THE IMAGE WAS CONFIRMED. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDENDUM DEC 2, 2022: CUSTOMER REPORTED EVENT OCCURRED DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. IT IS NOT KNOWN WHEN DURING THE PROCEDURE THE EVENT OCCURRED. THERE WAS NO DELAY IN THE COMPLETION OF THE PROCEDURE. SIMPLE INSPECTION OF THE DEVICE WAS PERFORMED PRIOR TO THE PROCEDURE WITH NO ANOMALY NOTED AND NO IMAGE NOISE.

    Description of Event or Problem · 0

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF NOISE IN THE IMAGE ISSUE. THERE IS NO REPORTED HARM TO ANY PATIENT OR HEALTH CARE PROFESSIONAL. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE IS PRESENCE OF FOREIGN MATERIAL CLOGGING THE NOZZLE. THIS IS ATTRIBUTED TO INSUFFICIENT CLEANING. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF FOREIGN MATERIAL FOUND IN THE NOZZLE DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237220 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-PQ260L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown