BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB

    MDR report key: 22667667 · Received July 30, 2025

    Report

    Report Number
    9610617-2025-01315
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 8, 2025
    Report Date
    April 28, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OAY
    UDI-DI
    04048551004654
    PMA / PMN Number
    P050027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OUR CANADIAN FACILITY, AND WILL LATER BE FORWARDED TO THE MANUFACTURING SITE FOR 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 DURING A TURBT PROCEDURE ON (B)(6) 2025, THE UROLOGIST WAS USING BLUE LIGHT TO TAKE TISSUE SAMPLES TO CONFIRM IF THE PATIENT REQUIRED A CYSTECTOMY OR NOT. THE UROLOGIST RESECTED USING WHITE LIGHT BUT WAS NOT ABLE TO USE THE BLUE LIGHT TECHNOLOGY TO CONFIRM HE HAD REMOVED ALL OF THE CIS (CARCINOMA IN SITU). HE DID TRY TO GET A BIOPSY WHERE HE THOUGHT HE SAW THE ILLUMINATION AS THE LIGHT WORKED THE FIRST TIME, HE ACTIVE THE BLUE LIGHT BUT DIDN'T FOR THE ADDITIONAL ATTEMPTS. AFTER HE BIOPSIED, HE WENT ON TO RESECT THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183135 COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB OAY KARL STORZ SE & CO. KG 20133620-133 04048551004654

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other| R