BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISIO NAVIGATION SYSTEM

    MDR report key: 19197641 · Received April 26, 2024

    Report

    Report Number
    3014653199-2024-00001
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    March 29, 2024
    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

    ALTHOUGH THE SUBJECT DEVICE WAS NOT RETURNED, THE COMPANY CONDUCTED A COMPLAINT INVESTIGATION. THE COMPLAINT INVESTIGATION CONFIRMED THAT TWO PINK SMARTCLIPS WERE PLACED IN THE PATIENT. THE ENVISIO NAVIGATION SYSTEM IS UNABLE TO PROVIDE RELIABLE SOLUTIONS FOR TWO SAME COLOR CLIPS SINCE SMARTCLIPS OF THE SAME COLOR OPERATE AT THE SAME FREQUENCY. AS STATED IN THE LABELING, THE ENVISIO NAVIGATION SYSTEM SHOULD NOT BE USED WITH TWO SAME COLOR CLIPS. DURING THE CASE, THE SURGEON WAS ADVISED BY ELUCENT MEDICAL TO USE AN ALTERNATE METHOD SUCH AS ULTRASOUND TO REMOVE ONE SMARTCLIP, THEN THEY COULD USE THE ENVISIO NAVIGATION SYSTEM TO REMOVE THE SECOND SMARTCLIP. THE SURGEON CHOSE TO PROCEED WITH THE ENVISIO NAVIGATION SYSTEM FOR THE REMOVAL OF BOTH SMARTCLIPS.

    Description of Event or Problem · 0

    DURING A CASE USING THE ENVISIO¿ NAVIGATION SYSTEM, IT WAS REPORTED THAT TWO 'PINK' SMARTCLIPS WERE IMPLANTED IN THE SAME PATIENT. THIS EVENT COINCIDED WITH EXCESS TISSUE REMOVAL FROM THE PATIENT. (SMARTCLIP SOFT TISSUE MARKERS ARE AVAILABLE IN THREE DIFFERENT VERSIONS, PINK, GREEN AND PURPLE. THE SMARTCLIP VERSIONS ARE IDENTICAL IN MATERIALS OF CONSTRUCTION, BUT ARE DIFFERENTIATED BY DIFFERENT FREQUENCIES THEY EMIT WHEN LOCALIZED BY THE ENVISIO NAVIGATION SYSTEM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039308 ENVISIO NAVIGATION SYSTEM ENVISIO NAVIGATION SYSTEM NEU ELUCENT MEDICAL, INC. N/A 00851674008034

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Disability