BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO URETERO-RENOSCOPE FLEX-XC1

    MDR report key: 24531369 · Received March 6, 2026

    Report

    Report Number
    1221826-2026-00459
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Report Date
    March 6, 2026
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    UDI-DI
    04048551428016
    PMA / PMN Number
    K212458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT 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

    THE FOLLOWING WAS REPORTED: A 091271-01 FAILED DURING A CASE. HE STATED A LASER GET STUCK WHEN BEING PUT THROUGH THE WORKING CHANNEL. IT GETS STUCK AT THE POINT THE CHANNEL STARTS TO BEND. TOOK THE 10 TRIES TO GET IT TO PASS THROUGH AND THEY WERE ABLE TO COMPLETE THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592078 VIDEO URETERO-RENOSCOPE FLEX-XC1 VIDEO URETERO-RENOSCOPE FLEX-XC1 FGB KARL STORZ ENDOVISION 091271-01 202511101 04048551428016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown