BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 24491574 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14703
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 2, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874123369
    PMA / PMN Number
    K250674
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND WAS TOLD THE ISSUE WAS RESOLVED OVER THE PHONE. NO SITE VISIT WAS REQUIRED. AN ADVANCED VESSEL SEALER INSTRUMENT LOG REVIEW WAS COMPLETED BY FAILURE ANALYSIS ENGINEERING. E-200 ACTIVATION EVENTS FOR THIS PROCEDURE SHOW 15 BIPOLAR EVENTS WITH NO ERRORS AND 85 SEAL EVENTS WITH 1 ERROR. THE INSTRUMENT WAS USED FOR ABOUT 58 MINUTES. NOTHING IN THE LOG'S POINTED TO A POSSIBLE DEFINITIVE CAUSALITY PERTAINING TO THE CUSTOMER¿S COMPLAINT. THE PROBABLE ROOT CAUSE OF THE CUSTOMER-REPORTED EVENT BASED ON EVALUATION OF INSTRUMENT LOGS BY FAILURE ANALYSIS ENGINEERING MAY POSSIBLY BE DUE TO THE HIGH IMPEDANCE EVENT WHICH TYPICALLY OCCURS DUE TO THE USER TRYING TO SEAL EXCESSIVE TISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS NOT GETTING HEMOSTASIS WHEN USING A CURVED VESSEL SEALER INSTRUMENT. THE CUSTOMER INQUIRED ON WHERE TO PLUG IN THE INSTRUMENT ON THE DV5 SYSTEM. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER THAT THEY NEEDED TO CONNECT THE INSTRUMENT TO THE E-200 GENERATOR. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS PLUGGED INTO THE LOWER BIPOLAR PORT. THE TSE RECOMMENDED TO TRY THE TOP BIPOLAR PORT OR A NEW INSTRUMENT. THE TSE INFORMED THE CUSTOMER THAT THEY COULD CONNECT THE BACKUP E-200 IF THE ISSUE CONTINUED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550399 DA VINCI ENERGY VESSEL SEALER CURVED NAY INTUITIVE SURGICAL, INC 480522-02 U10250902 0215 10886874123369

    Patients

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