BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISIO NAVIGATION SYSTEM

    MDR report key: 17761082 · Received September 15, 2023

    Report

    Report Number
    3014653199-2023-00001
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 15, 2023
    Manufacturer
    ELUCENT MEDICAL, INC.
    Product Code
    NEU
    UDI-DI
    00851674008072
    PMA / PMN Number
    K183400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE SUBJECT DEVICE WAS NOT RETURNED, THE COMPANY CONDUCTED A COMPLAINT INVESTIGATION. IN ADDITION, A COMPANY FIELD REPRESENTATIVE WAS PRESENT AT THE CASE. THE COMPLAINT INVESTIGATION DETERMINED THAT THE NAVSLIM WAS COMMUNICATING SUCCESSFULLY FROM THE TIME IT WAS DISCOVERED THAT SEPARATION HAD OCCURRED TO THE TIME IT WAS REPLACED WITH A NEW NAVSLIM. EVEN THOUGH THE COMPANY WAS NOT ABLE TO ESTABLISH A CONNECTION BETWEEN THE SEPARATION OF THE NAVSLIM AND THE EXCESS TISSUE REMOVAL, THE COMPANY IS SUBMITTING THIS MDR IN AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 0

    DURING A CASE USING THE ENVISIO¿ NAVIGATION SYSTEM, IT WAS REPORTED THAT THE NAVSLIM COMPONENT BECAME SEPARATED FROM THE ELECTROCAUTERY TOOL. A NEW NAVSLIM WAS CONNECTED. THIS EVENT COINCIDED WITH EXCESS TISSUE REMOVAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315580 ENVISIO NAVIGATION SYSTEM ENVISIO NAVIGATION SYSTEM NAVSLIM NEU ELUCENT MEDICAL, INC. 13761 00851674008072

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Other