BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25210498 · Received May 18, 2026

    Report

    Report Number
    2955842-2026-25545
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 18, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 ARRIVED ON SITE, STARTED THE SYSTEM, AND IT IMMEDIATELY GENERATED ERROR 40006. THE FSE INITIATED THE UNIVERSAL SURGICAL MANIPULATOR (USM) REPLACEMENT WORKFLOW, AS INDICATED BY THE ERROR LOGS. AFTER THE USM WAS INSTALLED AND THE WORKFLOW CONTINUED, AN APERTURE ERROR INDICATED THAT THE USM COMPUTE ENGINE (UCE-2) WAS NOT PRESENT, ALONG WITH THE USM2 NODES. THE FSE SWAPPED THE FIBER CABLES TO THE CORRESPONDING ARMS ON THE CARD CAGE BACKPLANE, AND THE ERROR DID NOT FOLLOW. THE FSE THEN RETURNED THE FIBER CABLES TO THEIR ORIGINAL LOCATIONS AND SWAPPED PCE-1 AND PCE-2. THE ERROR FOLLOWED PCE-2, AND ARMNET 1 THEN WENT DOWN. THE FSE PERFORMED THE PCE REPLACEMENT WORKFLOW, BUT THE UNIT DID NOT PROGRAM PROPERLY. THE NEXT DAY, THE FSE STARTED THE SYSTEM AND ENCOUNTERED ERROR 40096. THE FSE REPLACED THE CARD CAGE BECAUSE THE PCE-2 REPLACEMENT PERFORMED THE PREVIOUS DAY DID NOT RESOLVE THE ISSUE. AFTER THE CARD CAGE WAS REPLACED, THE SYSTEM WAS ABLE TO START IN NORMAL MODE WITH NO ERRORS. THE ERROR LOGS WERE FREE OF ISSUES AFTER A HARD POWER CYCLE OF THE ENTIRE SYSTEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, FAILURE ANALYSIS HAS NOT YET COMPLETED THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THEY ARE EXPERIENCING AN ISSUE WITH ARM 2. THE TSE REVIEWED SYSTEM LOGS AND CONFIRMED 319 ERRORS ASSOCIATED WITH ARM NETWORK 2, THEN PROVIDED INSTRUCTIONS ON HOW TO DISABLE THE AFFECTED ARM UPON REQUEST. THE CALLER LATER REPORTED THE SYSTEM WAS HARD POWER-CYCLED AND INITIALLY RETURNED WITHOUT ERROR; THE TSE ADVISED THAT THE ISSUE COULD RECUR AND NOTED CONTINUED USE WOULD BE A CLINICAL DECISION. WHILE THE TSE WAS REVIEWING LOGS, THE CALLER REPORTED THE SYSTEM WAS ABLE TO HOME BUT THE ERRORS RETURNED WITH PROMPTS TO DISABLE MULTIPLE ARMS, AND THE PROCEDURE WAS MOVED TO ANOTHER SYSTEM. THE CLINICAL SALES REPRESENTATIVE (CSR) LATER CALLED AND REITERATED THE SAME ARM 2 AND MULTIPLE-ARM DISABLE MESSAGE SITUATION, AND THE TSE STATED THIS INFORMATION HAD ALREADY BEEN DISCUSSED AND SYSTEM IS CURRENTLY MARKED AS SYSTEM DOWN. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395351 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1