BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 8613852 · Received May 15, 2019

    Report

    Report Number
    1723170-2019-02375
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    UDI-DI
    00643169584440
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SOFT TISSUE ABLATION. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE VCLAS 001-4000 .4 MM CORE FIBER 10 MM TIP SET. THE LASER REPORTEDLY WOULDN'T FUNCTION, AND UPON FURTHER INSPECTION, IT WAS FOUND THAT THE SHEATHING INSIDE OF THE PACKAGING WAS DAMAGED. THEY SWITCHED TO ANOTHER KIT TO PROCEED. ISSUE OCCURRED INTRA/PERI-OPERATIVELY WITH 20 MINUTES DELAY TO SURGICAL TIME. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404702 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 002-1100 00643169584440

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR