BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISIO SYSTEM

    MDR report key: 22142107 · Received June 4, 2025

    Report

    Report Number
    3014653199-2025-00002
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 4, 2025
    Manufacturer
    ELUCENT MEDICAL, INC.
    Product Code
    NEU
    UDI-DI
    00851674008034
    PMA / PMN Number
    K183400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN A REVIEW OF THE CLINICAL CASE, THE ENVISIO SYSTEM WAS FOUND TO CONFIRM THE REPORTED SMARTCLIP DISPLACEMENT OCCURRED DURING NAVIGATION. THE SMARTCLIP WAS CONFIRMED TO HAVE BEEN REMOVED FROM THE PATIENT AS A RESULT OF ITS DISPLACEMENT DURING THE PROCEDURE. BASED ON THE REPORTED INFORMATION, THE DISPLACEMENT PREVENTED SURGICAL NAVIGATION RESULTING IN A SECOND SURGICAL RESECTION TO BE REQUIRED TO REMOVE INTENDED TISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NAVIGATION, THE SMARTCLIP WAS DISPLACED FROM THE TARGET LOCATION. THE DISPLACEMENT OF THE SMARTCLIP PREVENTED SURGICAL NAVIGATION RESULTING IN INCOMPLETE REMOVAL OF THE TARGET TISSUE. A SECOND SURGICAL PROCEDURE WAS REPORTED TO BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709604 ENVISIO SYSTEM ENVISIO NEU ELUCENT MEDICAL, INC. ENVISIO-SYS 00851674008034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention