BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 16752775 · Received April 17, 2023

    Report

    Report Number
    3002808148-2023-03820
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 22, 2023
    Report Date
    May 18, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170310461
    PMA / PMN Number
    K221683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTED EVENT WAS NOT REPRODUCED. NO FOREIGN MATERIAL WAS IDENTIFIED. THE FOLLOWING CHAPTERS FROM THE INSTRUCTIONS FOR USE (IFU) PERTAINS TO THE EVENT, "CHAPTER 4 REPROCESSING WORKFLOW FOR ENDOSCOPES AND ACCESSORIES" AND "CHAPTER 5 REPROCESSING THE ENDOSCOPE". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY OLYMPUS. THE EVALUATION FOUND THAT THE ALLEGATION WAS NOT CONFIRMED, NO DEBRIS WAS DETECTED. ADDITIONAL ISSUES WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE DISTAL SHEATH WAS STRETCHED, AND THE DISTAL SHEATH GLUE WAS PEELED. . THE INVESTIGATION IS ONGOING, AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING, FOREIGN MATERIAL (DEBRIS) WAS FOUND INSIDE THE BIOPSY CHANNEL, 44CM FROM THE BIOPSY PORT ON THE CYSTO-NEPHRO VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827450 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VH 04953170310461

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown