BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14018014 · Received April 5, 2022

    Report

    Report Number
    8010047-2022-05740
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 16, 2022
    Report Date
    April 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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/WATER NOZZLE. THE LEGAL MANUFACTURER PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS AND CONFIRMED THE REFERENCED SCOPE WAS REPAIRED ON NOVEMBER 2, 2021 FOR A POOR AIR/WATER SUPPLY. 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 (OMSC) WAS INFORMED THAT THE CUSTOMER EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE WAS RETURNED FOR SERVICE/REPAIR FOR A REPORTED ¿CLOGGED AIR SUPPLY / WATER SUPPLY NOZZLE¿ DURING REPROCESSING AFTER THE CASE. THERE WERE NO PROBLEMS IDENTIFIED DURING PRE-CASE INSPECTION. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. UPON INSPECTING AND TESTING, THE SERVICE EVALUATION IDENTIFIED THAT THE AIR/WATER NOZZLE IS CLOGGED WITH A FOREIGN MATERIAL. NO HEALTH HAZARD TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695660 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-PQ260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown