BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694326 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17850
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 11, 2025
    Report Date
    April 8, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS DUE TO ISSUES WITH Q100 AND Q102 AND U15 CHIP ON THE MASTER COMPUTE ENGINE BOARD (MCEB) PRINTED CIRCUIT ASSEMBLY (PCA).

    Additional Manufacturer Narrative · 0

    ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MCEB WAS ANALYZED AND ERRORS 32139 AND 321451 RELATED TO THE FOOT TRAY MOTOR/BRAKES WERE SUCCESSFULLY REPRODUCED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. DURING BENCH TESTING, ERRORS 32139 AND 321451 RELATED TO THE FOOT TRAY MOTOR/BRAKES WERE SUCCESSFULLY REPRODUCED. FURTHER DIAGNOSTICS IDENTIFIED A POWER ERROR ON THE P48V LINE SUPPLYING THE FOOT TRAY MOTOR/BRAKES. A DIGITAL MULTIMETER (DMM) CHECK REVEALED THAT BOTH Q100 AND Q102 MOSFETS WERE SHORTED, AS CONFIRMED USING DIODE MODE. ADDITIONALLY, THE VOLTAGE AT PIN 9 OF U15 WAS MEASURED AT 0 V, CONSISTENT WITH THE FIELD-REPORTED ISSUES. IN ADDITION, DURING THE PROBING THE CAPACITOR C62 WAS SHORTED OUT/BURNED.

    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 TRAINING/DEMO OF THE DA VINCI SYSTEM, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT ERGONOMIC ERRORS APPEARED WHEN THE SYSTEM WAS POWERED ON. THE CALLER STATED THEY REBOOTED THE SYSTEM TWICE AND THE ERROR RETURNED ON BOTH POWER CYCLES. THE TSE ADVISED THE CSR TO PERFORM A HARD REBOOT ON THE SURGEON SIDE CONSOLE (SSC) AND VERIFY NOTHING WAS IMPEDING THE ERGO FEATURES FROM MOVING WHEN THE SYSTEM POWERS BACK ON. LATER, THE CSR CALLED BACK TO REPORT THAT PERFORMING A HARD POWER CYCLE AND MOVING THE SSC AROUND ENSURING NOTHING WAS OBSTRUCTING THE ERGONOMICS DID NOT RESOLVE THE PROBLEM. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275318 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-46 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1