BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 22371073 · Received July 1, 2025

    Report

    Report Number
    1723170-2025-02565
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 7, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GAH
    UDI-DI
    00763000416461
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) THE INSTRUMENT WAS RETURNED FOR ANALYSIS. AS REPORTED, THE RETURNED ANCHOR HAD A CRACK IN IT. 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 IN A LASER INTERSTITIAL THERMAL THERAPY PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX ISSUE WITH AN INSTRUMENT. DURING A CASE AND REMOVING INSTRUMENTS FROM THE PACKAGING, THE INSTRUMENT HAD A CRACK. THE SITE OPENED UP ANOTHER INSTRUMENT AND PROCEEDED WITH CASE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CRACK IN THE BONE ANCHOR WAS NOTICE DURING CASE SETUP AND HAD NO PATIENT INTERACTION. IT WAS THE WHITE PART OF BONE ANCHOR, BETWEEN THE WINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207036 VISUALASE STYLET, SURGICAL, GENERAL & PLASTIC SURGERY GAH MEDTRONIC NAVIGATION, INC 9735571 2025010024 00763000416461

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female