BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISIO NAVIGATION SYSTEM

    MDR report key: 17789290 · Received September 21, 2023

    Report

    Report Number
    3014653199-2023-00002
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    September 22, 2023
    Report Date
    September 20, 2023
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE SUBJECT DEVICE WAS NOT RETURNED, THE COMPANY CONDUCTED A COMPLAINT INVESTIGATION INCLUDING A PHYSICAL INSPECTION OF THE DEVICE AND USE ENVIRONMENT AT ITS LOCATION. THE COMPLAINT INVESTIGATION DETERMINED THAT A MALFUNCTIONING ELECTRONIC DEVICE (FROM A SEPARATE MANUFACTURER) WAS EMITTING A UNIQUE ELECTRONIC NOISE WHICH INTERFERED WITH THE ENVISIO NAVIGATION SYSTEM FOR APPROXIMATELY 2.5 MINUTES. THE EFFECT OF THIS INTERFERENCE WAS ERRATIC NAVIGATIONAL INFORMATION DISPLAYED BY THE ENVISIO NAVIGATION SYSTEM FOR THE 2.5 MINUTES OF INTERFERENCE AS THE ENVISIO NAVIGATION SYSTEM SOFTWARE RESPONDED TO THE PRESENCE OF THIS ELECTRONIC NOISE. ELUCENT NOTIFIED THE CUSTOMER OF THE MALFUNCTIONING EQUIPMENT.

    Description of Event or Problem · 0

    DURING A CASE USING THE ENVISIO¿ NAVIGATION SYSTEM, IT WAS REPORTED THAT THE SYSTEM NAVIGATION WAS SLOW OR LAGGING. THIS EVENT COINCIDED WITH EXCESS TISSUE REMOVAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986355 ENVISIO NAVIGATION SYSTEM ENVISIO NAVIGATION SYSTEM NEU ELUCENT MEDICAL, INC. N/A 00851674008034

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability