BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISIO SYSTEM

    MDR report key: 24408347 · Received February 20, 2026

    Report

    Report Number
    3014653199-2026-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 23, 2026
    Report Date
    January 23, 2026
    Manufacturer
    ELUCENT MEDICAL
    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

    MANUFACTURER REVIEW INCLUDED ANALYSIS OF SYSTEM EVENT HISTORY LOGS, WHICH CONFIRMED THE INITIALLY IMPLANTED CLIP WAS BRIEFLY DETECTED DURING THE INITIAL PROCEDURE SETUP BUT WAS NOT SUBSEQUENTLY RECOGNIZED BY THE SYSTEM. DURING THE SECOND PROCEDURE, LOCALIZATION AND EXCISION WERE SUCCESSFULLY COMPLETED USING A NEWLY IMPLANTED CLIP. THE CLIPS WERE NOT RETURNED FOR EVALUATION DESPITE REQUEST; THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED. THE MALFUNCTION WAS VERIFIED THROUGH LOG REVIEW; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. REVIEW OF HISTORICAL COMPLAINT DATA DID NOT IDENTIFY A RELATED TREND. NO ADVERSE CLINICAL SIGNS OR SYMPTOMS WERE REPORTED. THE EVENT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO COMPLETE LESION REMOVAL.

    Description of Event or Problem · 0

    A LOCALIZATION CLIP WAS IMPLANTED TO MARK A TARGET LESION PRIOR TO SURGICAL EXCISION. DURING THE SUBSEQUENT PROCEDURE, THE SYSTEM BRIEFLY DETECTED THE CLIP BUT WAS UNABLE TO MAINTAIN LOCALIZATION, AND THE PROCEDURE COULD NOT BE COMPLETED AS INTENDED. THE PATIENT LATER UNDERWENT A SECOND PROCEDURE DURING WHICH AN ADDITIONAL CLIP WAS IMPLANTED TO FACILITATE LOCALIZATION AND EXCISION. THE LESION WAS SUCCESSFULLY REMOVED. PATHOLOGY CONFIRMED BOTH CLIPS WERE PRESENT IN THE EXCISED SPECIMEN. THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462479 ENVISIO SYSTEM ENVISIO NEU ELUCENT MEDICAL ENVISIO-SYS 00851674008034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention