BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 11073670 · Received December 26, 2020

    Report

    Report Number
    8010047-2020-11011
    Event Type
    Malfunction
    Date Received
    December 26, 2020
    Date of Event
    December 1, 2020
    Report Date
    March 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC INSPECTED THE SUBJECT DEVICE AND FOUND SCRATCHES IN THE CONTROL SECTION, THE UNIVERSAL CORD, THE SCOPE CONNECTOR, AND THE DISTAL END COVER. THERE WAS DIRT ON THE UNIVERSAL CORD AND THE INSERTION SECTION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, WE PRESUME THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO INSUFFICIENT REPROCESSING OF THE USER.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUCTION CHANNEL AND THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR THE UNSPECIFIED MICROBES. THE DEVICE HAD BEEN REPROCESSED A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, ENDOCLENS NEO, USING PHTHARAL. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538131 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1