BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24721253 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19625
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 17, 2025
    Report Date
    March 27, 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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE MASTER CONTROL ELECTRONICS BOX (MCEB) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MCEB WAS ANALYZED, AND UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. A REVIEW OF ERROR LOGS REVEALED ERROR 32139, CONFIRMING THAT THE FAULT HAD OCCURRED IN THE FIELD. SPECIFICALLY, A HIGH-SIDE SWITCH ERROR 32139 WAS IDENTIFIED ON AXIS 3 OF THE ARMREST. THE MCEB WAS INSTALLED IN THE GOLDEN SYSTEM, WHICH IMMEDIATELY TRIGGERED ERROR 32139, INDICATING FAULTS WITH THE HIGH-SIDE SWITCH (HSS). FURTHER DIAGNOSTICS SHOWED A POWER ERROR ON THE P48V LINE (ARMREST MOTOR/BRAKES). A DIGITAL MULTIMETER (DMM) WAS THEN USED TO CHECK FOR SHORTS IN THE ARMREST HSS CIRCUIT. BOTH Q101 AND Q103 MOSFETS WERE VERIFIED TO BE FUNCTIONING PROPERLY WITH THE DMM SET TO DIODE MODE. HOWEVER, THE VOLTAGE MEASURED AT PIN 9 OF U14 FOR P48V_MOT_ARMRST WAS FOUND TO BE LOW (0V), CONSISTENT WITH THE COMPLAINTS REPORTED FROM THE FIELD. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE OF A U14 CHIP ON THE MASTER CONTROL ELECTRONICS BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED TECHNICAL SUPPORT TO REPORT THAT THE SYSTEM WAS PRESENTING AN ERGONOMICS ERROR AT START UP. THE CSR LATER ADVISED THAT ERROR 32139 WAS PRESENT AT START UP. PRIOR TO CALLING, THE SYSTEM WAS RESTARTED WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER INSTRUCTED THE CSR TO PERFORM A HARD POWER CYCLE ON THE SURGEON CONSOLE WITH NO CHANGE. THE CSR WAS ABLE TO DISABLE THE ERGONOMICS, BUT COULD NOT CONFIRM IF THE SURGEON WOULD BE ABLE TO PROCEED WITH THE PROCEDURE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415684 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-46 N/A 00886874119747

    Patients

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