BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTCLIP LITE SOFT TISSUE MARKER

    MDR report key: 24521421 · Received March 5, 2026

    Report

    Report Number
    MW5184797
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 2, 2026
    Manufacturer
    ELUCENT MEDICAL INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, IT WAS NOTED THAT THE SMARTCLIP MARKER COULD NO LONGER BE VISUALIZED- IT WAS NOT CONNECTING TO THE ENVISIO MAPPING SYSTEM. THIS CLIP WAS REQUESTED TO BE RETURNED TO THE REP AFTER REPORTING TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584268 SMARTCLIP LITE SOFT TISSUE MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU ELUCENT MEDICAL INC. 11636872

    Patients

    Seq Age Sex Outcome Treatment
    1 Female