BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24691909 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17856
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 28, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE PATIENT SIDE CART (PSC) PCE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN VIA LIGHTHOUSE REVIEW LOGS, ERRORS 319 AND 48305 WERE FOUND CONFIRMING THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PCE WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THEN TEN POWER CYCLES WERE PERFORMED, THE CCC LEFT IN THE GOLDEN SYSTEM TO IDLE FOR 76 HOURS WITH NO ISSUES FOUND. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE SYSTEM ENTERED A FAILURE STATE AND DISPLAYED A BOOM FAULT MESSAGE THAT COULD ONLY BE DISABLED. ERROR 48305 WAS OBSERVED, AND THE CLINICAL SALES REPRESENTATIVE (CSR) WANTED TO STOW THE BOOM, BUT IT WAS NO LONGER POSSIBLE DUE TO THE FAULT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459546 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1