BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 14354905 · Received May 11, 2022

    Report

    Report Number
    1723170-2022-00718
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 11, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GAH
    UDI-DI
    00763000416461
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE BONE ANCHOR SCREW WAS DAMAGED WHILE ATTEMPTING TO REMOVE THE UNIT POST-OPERATIVE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789538 VISUALASE STYLET, SURGICAL, GENERAL & PLASTIC SURGERY GAH MEDTRONIC NAVIGATION, INC 9735571 2021030879 00763000416461

    Patients

    Seq Age Sex Outcome Treatment
    1 Male