BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 20087744 · Received August 28, 2024

    Report

    Report Number
    1723170-2024-02402
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 19, 2024
    Report Date
    August 28, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: MC-VISUALASE, SERIAL/LOT #, UBD: UNKNOWN, UDI#: UNKNOWN. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON BOOTUP, THE SYSTEM DISPLAYED ERROR 162 ("162 - SYSTEM OPTIONS NOT SET. YOUR SYSTEM CONFIGURATION HAS CHANGED SINCE YOUR LAST BOOT. ADDITION OF A HARD DRIVE, ETC., OR LOSS OF POWER TO THE REAL TIME CLOCK HAS OCCURRED. PRESSING F1 WILL RECORD THE NEW CONFIGURATION. IF THIS MESSAGE PERSISTS, YOU MAY NEED TO REPLACE THE ONBOARD BATTERY."). TROUBLESHOOTING WAS PERFORMED. THE LOCAL REPRESENTATIVE (REP) WAS ABLE TO PROCEED BY PRESSING F1 AND RESETTING THE DATE AND TIME. THE SYSTEM WAS OPERABLE. IT WAS NOTED THAT THE SUSPECTED CAUSE OF THE ISSUE WAS A MALFUNCTIONING COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179878 VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC 9735542 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...