BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 25153278 · Received May 12, 2026

    Report

    Report Number
    1045254-2026-00663
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GEX
    UDI-DI
    00763000416430
    PMA / PMN Number
    K053087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED PRIOR TO A PROCEDURE DURING SETUP. IT WAS REPORTED THAT UPON OPENING THE LASER DIFFUSING FIBER (LDF), THE SURGEON INSPECTED THE LASER AND NOTICED A MINOR KINK/IMPERFECTION IN THE OPTICAL FIBER NEAR THE TIP. A NEW LDF WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591651 VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC XOMED INC. 9735560 0231692367 00763000416430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown