BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO URETERO-RENOSCOPE FLEX-XC1

    MDR report key: 24502341 · Received March 3, 2026

    Report

    Report Number
    1221826-2026-00420
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 3, 2026
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    UDI-DI
    04048551428023
    PMA / PMN Number
    K212458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMAGE INTERFERENCE OCCURRED THROUGHOUT THE DEVICE'S USE IN THE PROCEDURE AND INTERMITTENT IMAGE LOSS OCCURRED AS WELL. SCOPE HAD TO BE SWITCHED OUT TO COMPLETE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556339 VIDEO URETERO-RENOSCOPE FLEX-XC1 VIDEO URETERO-RENOSCOPE FLEX-XC1 FGB KARL STORZ ENDOVISION 091279-01 202512031 04048551428023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown