BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 10926336 · Received December 1, 2020

    Report

    Report Number
    8010047-2020-09643
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Report Date
    December 1, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K062049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. 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. HOWEVER BASED ON THE REPORT OF OLYMPUS KOREA AND THING WHICH IT WAS FOUND THE INSERTION TUBE OF THE SUBJECT DEVICE WAS DAMAGED AT THE INCOMING INSPECTION, OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO THE OCCURRENCE OF THE INSERTION TUBE DAMAGE. THE REPORTED PHENOMENON MIGHT HAVE OCCURRED AS SOON AS THE INSERTION TUBE DAMAGE WAS HAPPENED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THE ANGULATION OF THE SUBJECT DEVICE WAS NOT WORKED WHICH MIGHT BE OCCURRED DUE TO CUT OF THE ANGULATION WIRE DURING THE INCOMING INSPECTION FOR THE REPAIR AT OLYMPUS KOREA. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394516 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-VHA

    Patients

    Seq Age Sex Outcome Treatment
    1