BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO URETEROSCOPE, 8.5 FR. X 700MM

    MDR report key: 24676403 · Received March 24, 2026

    Report

    Report Number
    1221826-2026-00613
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 29, 2026
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    PMA / PMN Number
    K141250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 THAT THE SHEATH IS PEELING OFF AT END. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351944 VIDEO URETEROSCOPE, 8.5 FR. X 700MM VIDEO URETEROSCOPE, 8.5 FR. X 700MM FGB KARL STORZ ENDOVISION R11278VSUEK

    Patients

    Seq Age Sex Outcome Treatment
    1