BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 12670490 · Received October 21, 2021

    Report

    Report Number
    8010047-2021-13471
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM THE USER, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE INAPPROPRIATE AND/OR INSUFFICIENT REPROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, IT WAS FOUND THAT THE YELLOW LIQUID HAD BEEN DROPPING FROM THE DISTAL END OF THE SUBJECT DEVICE WHILE THE SUBJECT DEVICE WAS STORED IN THE CABINET WITH HANGING AND THE CUSHION SHEET UNDER THE SUBJECT DEVICE HAD BEEN PEELED OFF. THIS PHENOMENON WAS FOUND TWO DAYS AFTER THE STORING FOR DRYING THE SUBJECT DEVICE. THE USER ALSO REPORTED THAT THE NURSE IN CHARGE OF THE REPROCESS HAD FORGOTTEN TO CONNECT THE CONNECTING TUBE TO THE SUBJECT DEVICE DURING THE REPROCESS AND THIS PHENOMENON WAS ATTRIBUTED TO THE USER HANDLING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570215 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1