BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO1

    MDR report key: 24086685 · Received January 15, 2026

    Report

    Report Number
    3008776287-2026-00022
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 15, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    FGB
    UDI-DI
    00724995209179
    PMA / PMN Number
    K231878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY FILED MEDWATCH REPORT (B)(4) WHICH STERIS RECEIVED ON JANUARY 22, 2026. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING FOLLOW-UP MEDICAL DEVICE REPORT (MDR) 3008776287-2026-00022-01 SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR PROCEDURES AND POLICIES. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE SUBJECT OF THE REPORTED EVENT HAS BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE IMAGE TO THEIR URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE FROZE DURING A PATIENT PROCEDURE CREATING A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141015 URETERO1 URETEROSCOPE FGB BLACK DIAMOND VIDEO, INC. URORD101 (10)BSLC3774 00724995209179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown