BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE GUIDED LASER ABLATION SYSTEM

    MDR report key: 8913604 · Received August 20, 2019

    Report

    Report Number
    1723170-2019-04568
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    August 13, 2019
    Report Date
    November 12, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735559, SERIAL/LOT #: (B)(4), UBD: 25-JUN-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE LASER DIFFUSING FIBER (LDF) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LDF WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SOFT NEURO TISSUE ABLATION PROCEDURE, THE LASER OF THE ABLATION SYSTEM WOULD NOT FUNCTION WHEN POWERED ON. IT WAS REPORTED THAT THE LASER FIBERS WERE SWAPPED, WHICH RESTORED FUNCTIONALITY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703640 VISUALASE GUIDED LASER ABLATION SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 002-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR