BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISIO SYSTEM

    MDR report key: 21268651 · Received January 29, 2025

    Report

    Report Number
    3014623199-2023-00001
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 29, 2025
    Manufacturer
    ELUCENT MEDICAL
    Product Code
    NEU
    UDI-DI
    00851674008034
    PMA / PMN Number
    K183400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN A REVIEW OF THE CLINICAL CASE, THE PRESENCE OF THE GROUNDING PAD ABOVE THE ENVISIO PATIENT PAD WAS CONFIRMED. TESTING CONFIRMED THAT A GROUNDING PAD POSITIONED ABOVE THE PATIENT PAD MAY RESULT IN COMPROMISED NAVIGATION. IT WAS ALSO CONFIRMED THAT DEPENDING ON THE LOCATION ABOVE THE PATIENT PAD, THE GROUNDING PAD MAY HEAT AND COULD RESULT IN TISSUE DAMAGE. BOTH THE OPERATING MANUAL AND PATIENT PAD DECAL HAVE INSTRUCTIONS TO PLACE ALL GROUNDING PADS FOOTWARD AWAY FROM THE PATIENT PAD. BASED ON THE POTENTIAL TO HAVE COMPROMISED NAVIGATION, THERE WAS NO DEVICE MALFUNCTION DETERMINED TO OCCUR BASED ON THE REPORTED INFORMATION. THIS IS THE ONLY REPORTED CASE OF DEVICE-TO-DEVICE INTERACTION WITH A GROUNDING PAD IN OVER 18,000 CLINICAL CASES WITH THE ENVISIO SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NAVIGATION, THE ENVISIO SYSTEM WAS NOT CONSISTENTLY DISPLAYING NAVIGATION TO THE TARGETED CLIP. AFTER THE CASE WAS CONCLUDED, THE GROUNDING PAD WAS FOUND TO BE OVERLAPPING THE PATIENT PAD. WHEN THE GROUNDING PAD WAS REMOVED, A BLISTER WAS FOUND ON THE PATIENT BENEATH WHERE THE GROUNDING PAD WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780280 ENVISIO SYSTEM ENVISIO NEU ELUCENT MEDICAL N/A 00851674008034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability