BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24541366 · Received March 7, 2026

    Report

    Report Number
    2955842-2026-15437
    Event Type
    Malfunction
    Date Received
    March 7, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 7, 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
    TX, 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. FSE VERIFIED ERROR 17 WAS POINTING TO UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND PATIENT SIDE CART COMPUTE ENGINE (PCE) 2. THE FSE REPLACED USM 2 AND PCE 2. 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. THE USM WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ERROR 17 WAS CONFIRMED IN THE FIELD LOGS AND REPLICATED DURING FAILURE ANALYSIS. THE UNIT WAS INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND TRIGGERED ERROR 319 ON FIRST POWER UP. ON THE 2ND ATTEMPT, IT WAS ABLE TO RUN SINE CYCLE, BUT ERRORED OUT WITH COMMUNICATION ERRORS ON C, D, E BOARDS AND FIBER FAILED ON AXES CONTROLLER SPAR (ACS) UP. AFTER REPLACING THE PARALLELOGRAM FIBER, FIBER TEST PASSED AND UNIT WAS ABLE TO RUN SINE CYCLE TEST 3 TIMES WITH NO ERRORS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. FAILURE ANALYSIS IDENTIFIES THE PARALLELOGRAM FIBER TO BE THE ROOT CAUSE OF THE REPORTED EVENT. THE PCE WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ERROR 17 WAS CONFIRMED TO HAVE OCCURRED IN THE FIELD, BUT WAS NOT REPLICATED. AN ERROR 17 WAS FOUND VIA THE FIELD ERROR LOGS 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. TEN POWER CYCLES WERE PERFORMED AND THE COMMON COMPUTE CONTROLLER (CCC) WAS LEFT IN THE GOLDEN SYSTEM TO IDLE FOR 41 HOURS WITH NO ISSUES FOUND. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO REPORTED EVENTS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERROR 17 PRIOR TO DOCKING. BEFORE CALLING, THE CALLER HAD POWER CYCLED THE SYSTEM, BUT THE ERROR PERSISTED. ERROR 17 AND OTHER ERRORS WERE OBSERVED ON ROBOT ARMNET 2. TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CALLER TO CONFIRM THAT ALL BLUE FIBER CABLES WERE FULLY SEATED AND TO PERFORM AN EMERGENCY POWER OFF (EPO) ON THE ROBOT. THE SYSTEM COMPLETED POST, BUT ABOUT FIVE MINUTES LATER, ERROR 17 ON ARMNET 2 PERSISTED. THE SURGEON CHOSE NOT TO PROCEED WITH A THREE-ARM CASE AND, WITH NO OTHER SYSTEMS AVAILABLE, ABORTED THE PROCEDURE. THE PROCEDURE WAS ABORTED AFTER ANESTHESIA AND PORT-PLACEMENT WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455089 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-40 N/A 00886874119716

    Patients

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