BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 22556422 · Received July 21, 2025

    Report

    Report Number
    1723170-2025-02746
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    July 15, 2025
    Report Date
    July 21, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    GAH
    UDI-DI
    00643169933415
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A05: ADHESION NOT HOLDING, STYLET DIFFICULT TO INSERT A0504: SALINE LEAK D10: PRODUCT ID: UNK_VISUALASE_SYS (SERIAL: (B)(6); PRODUCT ID: 9735571 (2018101251); PRODUCT TYPE: 2543-MNAV - SYSTEM; H3, H6: NO PRODUCTS WERE 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 OUTSIDE OF A PROCEDURE. WHILE WALKING THROUGH A DEMONSTRATION, IT WAS NOTICED THAT THERE WAS A SALINE LEAK/DRIP AT THE BLUE STRAIN RELIEF SHEATH WHILE IN THE MAGNETIC RESONANCE IMAGING (MRI) MACHINE. TOWELS WERE USED TO CONTAIN THE DRIPPAGE AND CLEAN IT UP WITH NO APPARENT DAMAGE CAUSED. AFTER THE DRY RUN, IT WAS NOTICED THAT THE LOCAL REPRESENTATIVE (REP) COULD JUST PULL THE OUTER CANULA OF THE INNER CANULA/LUMEN AS IF THE ADHESION SPOT INSIDE THE BLUE STRAIN RELIEF WAS NOT HOLDING. THE REP HAD ALSO NOTICED WHEN THEY SET UP THAT THE STIFFENING STYLET WAS SLIGHTLY DIFFICULT TO INSERT, BUT IT DID PASS WITH SOME FRICTION. IT WAS NOTED THAT THE ACCESSORY KIT WAS "WAY" PAST EXPIRATION DATE. IT HAD EXPIRED ON 2020-OCT-25. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037525 VISUALASE STYLET, SURGICAL, GENERAL & PLASTIC SURGERY GAH MEDTRONIC NAVIGATION, INC. 9735571 2018101251 00643169933415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown