BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 9961859 · Received April 15, 2020

    Report

    Report Number
    8010047-2020-02214
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Report Date
    May 24, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER, IT WAS FOUND THE RUST ON THE FORCEPS ELEVATOR OF THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425301 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1