BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO URETERO-RENOSCOPE FLEX-XC1

    MDR report key: 24531374 · Received March 6, 2026

    Report

    Report Number
    1221826-2026-00457
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 6, 2026
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    UDI-DI
    04048551428030
    PMA / PMN Number
    K212458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THE SCOPE HAD A POOR VIDEO OUTPUT, WITH A PINK HUE ACROSS THE IMAGE. THE CASE WAS DELAYED BY 5 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592349 VIDEO URETERO-RENOSCOPE FLEX-XC1 VIDEO URETERO-RENOSCOPE FLEX-XC1 FGB KARL STORZ ENDOVISION 091279-06 202512111 04048551428030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown