BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12726713 · Received November 1, 2021

    Report

    Report Number
    8010047-2021-13873
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Report Date
    November 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT THERE WAS A POSSIBILITY OF INSUFFICIENT REPROCESSING OR HANDLING PROBLEM.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) ON OCTOBER 7, 2021, IT WAS FOUND THAT THE NOZZLE HAD A FOREIGN MATERIAL AND WAS CLOGGED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631997 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1