BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 14017773 · Received April 5, 2022

    Report

    Report Number
    8010047-2022-05737
    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 CONFIRMED THE CUSTOMER¿S REPORTED ISSUE AS THERE IS NO AIR/WATER FLOW AS FOREIGN MATERIAL, BELIEVED TO BE A PIECE OF SILICONE RUBBER, WAS FOUND CLOGGED INSIDE THE AIR/WATERE NOZZLE. ADDITIONALLY, THE BENDING ANGULATION IS INSUFFICIENT DUE TO A STRETCHED ANGLE WIRE, THE CONTROL KNOBS HAVE PLAY, THERE ARE SCRATCHES ON THE INSERTION TUBE, THE BENDING SECTION COVER ADHESIVE IS CRACKED, THE DISTAL TIP COVER IS CRACKED, THE LIGHT GUIDE LENS IS CRACKED, THE ADHESIVE OF THE OBJECTIVE LENS IS PEELED OFF, THERE ARE SCRATCHES ON THE PROTECTIVE BOOT COVER OF THE INSERTION TUBE. 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 THERE WAS NO PREVIOUS REPAIR HISTORY. 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 WAS INFORMED THAT THE CUSTOMER EVIS LUCERA ELITE COLONOVIDEOSCOPE WAS RETURNED FOR SERVICE/REPAIR FOR A REPORTED ¿CANNOT SENT WATER¿. UPON INSPECTING AND TESTING, THE SERVICE EVALUATION IDENTIFIED THAT THE AIR/WATER NOZZLE IS CLOGGED 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
    2341785 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown