BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 9735542 15W VISUALASE

    MDR report key: 6471630 · Received April 7, 2017

    Report

    Report Number
    1723170-2017-01491
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 10, 2017
    Report Date
    April 7, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    UDI-DI
    00643169792890
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE LASER DIFFUSING FIBER (LDF) WAS BURNT OUT ON THE UNIT. RESULTING IN DAMAGE TO THE COOLING CATHETER SYSTEM (CCS). THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A MRI GUIDED LASER ABLATION, A CHARRED CATHETER WAS FOUND ON THE SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255767 SYSTEM 9735542 15W VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 00643169792890

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR