BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISIO SYSTEM

    MDR report key: 25034309 · Received April 29, 2026

    Report

    Report Number
    3014653199-2026-00002
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ELUCENT MEDICAL
    Product Code
    NEU
    UDI-DI
    00851674008553
    PMA / PMN Number
    K183400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REVIEW WAS COMPLETED BASED ON AVAILABLE COMPLAINT INFORMATION AND SYSTEM CASE LOGS, AS THE SYSTEM REMAINED AT THE CUSTOMER SITE AND WAS NOT PHYSICALLY EVALUATED. REVIEW OF THE CASE LOGS, INCLUDING SETUP, CALIBRATION, SELF-TEST RESULTS, NAVIGATION DATA, POTENTIAL INTERFERENCE INDICATORS, AND COMPLAINT HISTORY, DID NOT IDENTIFY EVIDENCE OF SYSTEM MALFUNCTION OR INACCURACY. THE LOGS INDICATED THE USER NAVIGATED TO OR NEAR THE SMARTCLIP DURING THE SURGICAL EXCISIONS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED SYSTEM INACCURACY COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    DURING A LUMPECTOMY PROCEDURE, THE PHYSICIAN REPORTED A DISCREPANCY BETWEEN THE EXPECTED CLIP LOCATION AND THE SYSTEM-INDICATED LOCATION. INITIAL SPECIMENS DID NOT INCLUDE THE CLIP; THE CLIP WAS RETRIEVED IN A SUBSEQUENT EXCISION. THE PHYSICIAN REPORTED THE FINAL SPECIMEN WAS LARGER THAN INITIALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620499 ENVISIO SYSTEM ENVISIO NEU ELUCENT MEDICAL ENVISIO-SYS 00851674008553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention