BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 23550634 · Received November 13, 2025

    Report

    Report Number
    2955842-2025-45016
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 28, 2025
    Report Date
    April 1, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS COULD NOT REPLICATE OR CONFIRM THE COMPLAINT "THE POWER CONTINUED TO BE WEAK, AND THE VESSEL WAS NOT SEALED PROPERLY DURING USE." THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE BLADES OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED ENERGY DELIVERY TESTING IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT FAILED TO PERFORM THE SYNC TEST (DID NOT CUT). THE CUT ELECTRODE WAS FOUND TO HAVE THERMAL DAMAGE. MELTED CHAR MARKS WERE OBSERVED ALONG THE BLADE EDGE OF THE ELECTRODE. ANY MATERIAL MISSING IS LIKELY TO BE THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS LESS EFFECTIVE THAN EXPECTED AND IT DID NOT CUT TISSUE DURING THE SYNC FUNCTION. NO FRAGMENT FELL INTO PATIENT. THE ISSUE CAUSED A DELAY BETWEEN 15 AND 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595079 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 K10250306 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES