BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 13304281 · Received January 20, 2022

    Report

    Report Number
    8010047-2022-01687
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Report Date
    March 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION IS IN PROGRESS CURRENTLY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF THE OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE SUBJECT DEVICE. HOWEVER, THE SUBJECT NON-OLYMPUS (PIOLAX, INC.) DISPOSABLE CLEANING TOOL (SHINSENGUMI, MADE BY FELT CLOTH) WAS RETURNED TO OMSC AND THE DIRT ADHERED TO IT WAS ANALYZED. AS A RESULT OF THE COMPONENT ANALYSIS, ORGANIC SILICON WAS DETECTED. THE DIRT WAS LIKE GREASE, OMSC SURMISED THAT IT WAS CHEMICAL SOLUTION SUCH AS ANTIFOAM AGENT. CONSEQUENTLY OMSC CONSIDERED THAT THE DIRT WAS NOT MATERIAL COMPOSING ENDOSCOPE DEVICES, IT WAS DERIVED FROM THE OUTSIDE OF THE SUBJECT DEVICE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT CONFIRM THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE BECAUSE THE SERIAL NUMBER OF THE SUBJECT DEVICE WAS UNKNOWN, ALSO THE DEVICE MANUFACTURE DATE WAS UNKNOWN. THE EXACT CAUSE OF THE REPORTED PHENOMENON (DIRT ADHERING) COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE REPORTED INFORMATION, OMSC SURMISED THAT THE REPORTED PHENOMENON MIGHT HAVE BEEN CAUSED BY INSUFFICIENT CLEANING AND/OR RINSING. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE REPROCESSING BEFORE USE, WHEN THE USER CLEANED THE INSTRUMENT CHANNEL WITH NON-OLYMPUS (BIOLUX MEDICAL DEVICE CO., LTD.) CLEANING BRUSH, DIRT CAME OUT FROM THE INSTRUMENT CHANNEL. THE SUBJECT DEVICE HAD BEEN REPROCESSED AND HAD NOT BEEN USED DUE TO THE CANCELLATION OF PREVIOUS PROCEDURE. THE SUBJECT DEVICE HAD BEEN CLEANED WITH OLYMPUS CLEANING BRUSH BW-412T BEFORE. THERE WAS THE POSSIBILITY THAT THE INSUFFICIENTLY AND/OR INAPPROPRIATELY REPROCESSED SUBJECT DEVICE WAS USED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67597 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown