BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO URETERO-RENOSCOPE FLEX-XC1

    MDR report key: 23707231 · Received December 3, 2025

    Report

    Report Number
    1221826-2025-02205
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 11, 2025
    Report Date
    February 24, 2026
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    UDI-DI
    04048551428009
    PMA / PMN Number
    K212458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION SUMMARY: INVESTIGATIONAL ACTIVITIES SUGGEST MULTIPLE ROOT CAUSES COULD POTENTIALLY BE RELATED TO IMAGE QUALITY ISSUES. IN AN EFFORT TO FURTHER INVESTIGATE THE POTENTIAL ROOT CAUSES, WE HAVE INITIATED CAPA-25-0042. WE WILL CONTINUE TO TRACK AND TREND IMAGE QUALITY ISSUES. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    CONCLUSION SUMMARY: INVESTIGATIONAL ACTIVITIES SUGGEST MULTIPLE ROOT CAUSES COULD POTENTIALLY BE RELATED TO IMAGE QUALITY ISSUES. IN AN EFFORT TO FURTHER INVESTIGATE THE POTENTIAL ROOT CAUSES, WE HAVE INITIATED CAPA-25-0042. WE WILL CONTINUE TO TRACK AND TREND IMAGE QUALITY ISSUES. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED: THE PICTURE WILL GO IN AND OUT ON THE SCOPE AND HAS QUITE A BIT OF INTERFERENCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863674 VIDEO URETERO-RENOSCOPE FLEX-XC1 VIDEO URETERO-RENOSCOPE FLEX-XC1 FGB KARL STORZ ENDOVISION 091271-06 202503261 04048551428009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown