BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEOSCOPE "CYF-V2", EUROPEAN VERSION

    MDR report key: 9449137 · Received December 11, 2019

    Report

    Report Number
    8010047-2019-04239
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). (OBV). IN THE EVALUATION OF OBV THE FOLLOWING WAS CONFIRMED IN THE INSTRUMENT CHANNEL; THERE WAS NO FOREIGN MATERIALS, BUT THERE WAS A LOT OF DEBRIS DERIVED FROM THE INSTRUMENT CHANNEL MATERIAL. KINKED AT 20 CM FROM THE DISTAL END. THERE WAS HEAVY SCRATCHES. 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 FROM A FACILITY THAT IT FELT PARTICLES HAD COME OUT OF THE SUBJECT DEVICE DURING A THERAPEUTIC PROCEDURE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247204 VIDEOSCOPE "CYF-V2", EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1