BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO URETEROSCOPE, 8.5 FR. X 700MM

    MDR report key: 24078822 · Received January 15, 2026

    Report

    Report Number
    1221826-2026-00056
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 22, 2025
    Report Date
    February 25, 2026
    Manufacturer
    KARL STORZ SE & CO.KG
    Product Code
    FGB
    PMA / PMN Number
    K141250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION SUMMARY: NO IMAGE AND NO LIGHT. FLUID INVASION IN HANDLE HOUSING. LEAK FROM HANDLE HOUSING. NICKS ON DISTAL TIP. ROOT CAUSE OF HANDLE HOUSING LEAK WHICH CAUSED NO IMAGE AND NO LIGHT OUTPUT WAS IDENTIFIED ON ECM100007630 (EFFECTIVE 11/18/2024) AS A MANUFACTURING CHANGE TO THE HOUSING. KSE IS MONITORING THIS DEFECT WHICH IS CURRENTLY IN CONTROL. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO VIDEO IMAGE ON MONITOR. THERE WAS A DELAY OF LESS THAN 10 MIN TO RETRIEVE ANOTHER SCOPE FROM STERILE PROCESSING DEPARTMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140654 VIDEO URETEROSCOPE, 8.5 FR. X 700MM VIDEO URETEROSCOPE, 8.5 FR. X 700MM FGB KARL STORZ SE & CO.KG R11278VSUEK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown