BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 14017383 · Received April 5, 2022

    Report

    Report Number
    8010047-2022-05722
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Report Date
    April 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE EVALUATION IDENTIFIED THE AIR/WATER COULD NOT BE SUPPLIED DUE TO CLOGGING OF THE AIR/WATER NOZZLE WITH A FOREIGN MATERIAL, BELIEVED TO BE A PIECE OF SILICONE RUBBER. ADDITIONALLY, THERE WAS STAIN/DEBRIS ON THE CONTROL BODY, DEEP SCRATCHES AND SCRAPES ON THE SUCTION CYLINDER AND MOISTURE STAINS IN THE ELECTRICAL CONNECTOR. ALSO, THERE ARE COSMETIC SCRATCHES ON MULTIPLE COMPONENTS OF THE SCOPE SUCH AS: ON THE CONTROL BODY, ON THE ADJUSTMENT RING, THE SWITCH BOX HOUSING UNIT, ON THE RIGHT/LEFT CONTROL KNOB, SCRATCHES ON THE UNIVERSAL CORD AND THE SCOPE CONNECTOR. THE LEGAL MANUFACTURER PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CONCERNED DEVICE AND NO ABNORMALITIES WERE FOUND. A REVIEW OF THE REPAIR RECORDS CONFIRMED THAT A PREVIOUS REPAIR WAS PERFORMED IN DECEMBER 2021 FOR A DEFECTIVE. THE INVESTIGATION WAS COMPLETED BY THE LEGAL MANUFACTURER AND DETERMINED THAT THERE IS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. THE CAUSE OF THE INSUFFICIENT AIR/WATER SUPPLY IS DUE TO CLOGGING IN THE AIR/WATER NOZZLE. THE CAUSE OF THE REPORTED CLOGGING COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE POTENTIAL CAUSE MAY BE ATTRIBUTED TO A PIECE OF BROKEN RUNNER PACKING OF AIR/WATER VALVE OR WATER CONTAINER OR CHIPPED RUBBER PARTS FROM THE INJECTION TUBE (MH-946) THAT BECAME BROKEN AND STUCK INSIDE THE NOZZLE. IN GENERAL, THE CUSTOMER IS REQUIRED TO CHECK THE FUNCTION OF ALL DEVICES USED PRIOR TO A PROCEDURE AND A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED DURING AN APPLICATION. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS (OMSC) WAS INFORMED THAT THE CUSTOMER EVIS LUCERA COLONOVIDEOSCOPE WAS RETURNED FOR SERVICE/REPAIR FOR A REPORTED ¿RE-REPAIR REQUEST FOR A POOR AIR /WATER SUPPLY DURING FIRST USE¿. UPON INSPECTING AND TESTING, THE SERVICE EVALUATION IDENTIFIED THE AIR/WATER COULD NOT BE SUPPLIED DUE TO CLOGGING OF THE AIR/WATER NOZZLE WITH A FOREIGN MATERIAL. NO DEATH, INJURY, INFECTION OR HARM WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842232 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H260AI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown