BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 17044384 · Received June 1, 2023

    Report

    Report Number
    3002808148-2023-05537
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Report Date
    July 18, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411298
    PMA / PMN Number
    K221683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    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 OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: CAUTION ¿ DO NOT PULL THE UNIVERSAL CORD AND VIDEO CABLE DURING AN EXAMINATION. THE LIGHT GUIDE CONNECTOR WILL BE PULLED OUT FROM THE OUTPUT SOCKET OF THE LIGHT SOURCE AND THE ENDOSCOPIC IMAGE WILL NOT BE VISIBLE. ¿ DO NOT COIL THE INSERTION TUBE, UNIVERSAL CORD, OR VIDEO CABLE WITH A DIAMETER OF LESS THAN 10 CM. EQUIPMENT DAMAGE MAY RESULT. ¿ DO NOT ATTEMPT TO BEND OR TWIST THE ENDOSCOPE¿S INSERTION SECTION WITH EXCESSIVE FORCE. THE INSERTION SECTION MAY BE DAMAGED. ¿ DO NOT APPLY SHOCK TO THE DISTAL END OF THE INSERTION SECTION, PARTICULARLY THE OBJECTIVE LENS SURFACE AT THE DISTAL END. VISUAL ABNORMALITIES MAY RESULT. ¿ IF THE ENDOSCOPE IS DROPPED OR THE DISTAL END OF THE ENDOSCOPE RECEIVES A HARD IMPACT, THE ENDOSCOPE MAY BE DAMAGED EVEN IF NO VISIBLE DAMAGE OF THE LENS ON THE DISTAL END CAN BE FOUND. IN THIS CASE, STOP USING THE ENDOSCOPE, AND CONTACT OLYMPUS. ¿ DO NOT TWIST OR BEND THE BENDING SECTION WITH YOUR HANDS. EQUIPMENT DAMAGE MAY RESULT. ¿ DO NOT SQUEEZE THE BENDING SECTION FORCEFULLY. THE COVERING OF THE BENDING SECTION MAY STRETCH OR BREAK AND CAUSE WATER LEAKS. ¿ DO NOT PUT OR PRESS THE VIDEO CONNECTOR AND LIGHT GUIDE CONNECTOR ON THE INSERTION SECTION WHEN TRANSPORTING OR REPROCESSING. THE INSERTION SECTION MAY BE DAMAGED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    TO DATE, THIS DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS IS CONTINUING TO INVESTIGATE THE CUSTOMER¿S REPORT. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A MEDWATCH REPORT, SUBMITTED AS A VOLUNTARY REPORT TO THE FDA'S MEDWATCH PROGRAM, WAS FORWARDED BY THE FDA TO OLYMPUS FOR REVIEW. IT WAS REPORTED IN THE MEDWATCH THAT MULTIPLE CYSTO-NEPHRO VIDEOSCOPES AND URETERO-RENO FIBERSCOPES HAD INTRA-LUMINAL FIBERS DEVELOP INSIDE THE LUMEN. THE AFFECTED PROCEDURES WERE THERAPEUTIC AND DIAGNOSTIC. DUE TO THE REPORTED ISSUE, THE USER FACILITY STATED THAT PATIENT TREATMENT DELAYS OCCURRED AS THE AFFECTED SCOPES WERE SENT FOR REPAIR AND A LIMITED NUMBER OF SCOPES REMAINED ONSITE. THERE WAS NO REPORT OF PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED PROBLEM. THIS IS REPORT 9 OF 12, PATIENT IDENTIFIER (B)(6). REFERENCE THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328454 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VHR 04953170411298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown