BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 12858386 · Received November 22, 2021

    Report

    Report Number
    8010047-2021-14907
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 26, 2021
    Report Date
    February 3, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H4: MANUFACTURE DATE. 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 14 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. FROM THE RESULTS OF INVESTIGATION, FOREIGN DEBRIS CLOGGED AT THE NOZZLE DID NOT COME FROM THE SUBJECT DEVICE, BUT INSTEAD SEEMED LIKE WHITE RESIDUE OF A CHEMICAL AGENT AND/OR A PIECE OF FIBER FROM A CLEANING BRUSH. THE SUGGESTED EVENT WAS PRESUMED TO HAVE BEEN CAUSED BY THE FOLLOWING MECHANISMS: ·INSUFFICIENT REPROCESSING OF THE AIR/WATER CHANNEL WHICH ALLOWED CHEMICAL AGENTS OR A PIECE OF FIBER FROM THE CLEANING BRUSH TO REMAIN WITHIN THE NOZZLE; ·THE RESIDUE OF CHEMICAL AGENTS AND/OR A PIECE OF FIBER REMAINED WITHIN THE NOZZLE WERE DETECTED AS FOREIGN DEBRIS CLOGGED INSIDE THE NOZZLE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SERVICE INSPECTION INDICATED FOREIGN DEBRIS WAS FOUND PROTRUDING FROM THE AIR /WATER NOZZLE. THE DEBRIS APPEARED TO BE A WHITE COLORED RESIDUE AND CLEANING BRUSH FIBER. ADDITIONALLY, THE CUSTOMER 'S REPORT OF AS CRITICAL WEAR AT THE DISTAL END WAS OBSERVED CAUSING THE INNER METAL STRUCTURE TO BE EXPOSED. THE BENDING SECTION COVER WAS LEAKING. A REVIEW OF THE SCOPE'S PREVIOUS REPAIR RECORD INDICATES THE SCOPE WAS LAST SERVICED VIA REPAIR IN JANUARY 2020 DUE TO "LEAKING FROM SCOPEGUIDE". THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE/MALFUNCTION CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE OLYMPUS ((B)(4)) REGIONAL REPAIR CENTER WAS INFORMED THAT A CUSTOMER EVIS LUCERA COLONOVIDEOSCOPE WAS RETURNED DUE TO A REPORT OF "DISTAL END VISIBLY WORN-NO CLINICAL IMPACT" OBSERVED DURING REPROCESSING. HOWEVER, UPON INSPECTION AND TESTING, FOREIGN DEBRIS WAS IDENTIFIED INSIDE THE AIR / WATER NOZZLE. NO PATIENT INFECTION, INJURY OR HARM WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750962 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q260DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown