BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 3960850 · Received June 27, 2014

    Report

    Report Number
    2951238-2014-00256
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    OLYMPUS MEDIAL SYSTEM CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFO OR IF THE DEVICE IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TOWARD THE END OF A DIAGNOSTIC CYSTOSCOPY PROCEDURE, THE TIP OF THE CYSTO-NEPHRO VIDEOSCOPE BROKE OFF AND FELL INSIDE THE PT'S BLADDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE BROKEN PIECE WAS NOT RETRIEVED. HOWEVER, IT PASSED NATURALLY THROUGH THE URETHRA. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375952 OLYMPUS CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE KOG OLYMPUS MEDIAL SYSTEM CORPORATION CYF-VHR 2200148

    Patients

    Seq Age Sex Outcome Treatment
    1