BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24706755 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18816
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    December 15, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    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 PROXIMAL SETUP JOINT (PSUJ), FLEX, AND THE CARDCAGE TO RESOLVE THE REPORTED 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. THE PROXIMAL PSUJ WAS ANALYZED AND IN ARTEMIS, ERROR 31221 WAS FOUND INDICATING THAT THE HARDWARE HIGHSIDE SWITCH FAULT FIELD PROGRAMMABLE GATE ARRAY (FPGA) LOGIC DETECTED A LOSS OF POWER. IT WAS COUPLED WITH ERROR 319 INDICATING NODE NOT PRESENT AT STARTUP ACROSS ALL 3 NODES THUS CONFIRMING THAT THE FAULTS OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM IN NORMAL MODE WHERE ALL 3 NODES WERE MISSING AND HAD ERROR 31221 IN THE LOGS THUS REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE 3-NODE CHECK DURING PROGRAMMING. INSTALLED GOLDEN AXES CONTROLLER SETUP (ACU) WHICH WAS TESTED AND VERIFIED IT TO BE THE SOURCE OF THE FAULT. THE ORIENTING PLATFORM (OP) FLEX PATIENT SIDE CART (PSC) WAS ANALYZED AND THE ISSUE WAS REPLICATED ONSITE. CHECKED SYSTEM LOGS AND CONFIRMED ERRORS 319 AND 31221 HAD OCCURRED. PERFORMED TROUBLESHOOTING AND FOUND THAT ERRORS 319 AND 31221 POINT TO THE PSUJ AND FLEX ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 OF THE PSC. REPLACED BOTH PSUJ AND FLEX TO ADDRESS REPORTED ISSUE. PERFORMED VISUAL INSPECTION AND FOUND SCRATCHES AND BLEMISHES ON THE FLEX THAT WERE NOT RELATED TO REPORTED ISSUE. CHECKED LIGHTHOUSE/APERTURE AND CONFIRMED ERRORS 31221 AND 319 HAD OCCURRED. INSTALLED FLEX ON AN INTERNAL SYSTEM AND POWER CYCLED SEVERAL TIMES WITH NO ERRORS BUT UNABLE TO REPLICATE REPORTED ISSUE DURING SYSTEM TESTING. THE CARDCAGE PSC WAS ANALYZED AND IN ARTEMIS, ERROR 31221 AND 319 WAS FOUND INDICATING THE FAULT, CONFIRMING THE FAILURE OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, THE FILTER WAS FOUND DIRTY. THE CARDCAGE WAS INSTALLED ONTO THE GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE GOLDEN SYSTEM WAS SET TO RUN CALIBRATION AND SITTING IDLE FOR ONE HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/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 PRIOR TO THE START OF A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY (WITH LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE ERROR 31221. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THE ERROR 31221 AND 319 ON THE UNIVERSAL SURGICAL MANIPULATOR 1. THE CUSTOMER HARD POWER CYCLED THE SYSTEM, BUT THE ISSUE REMAINED. THE CUSTOMER RETRIEVED THE SPARE PATIENT SIDE CART FOR THE CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542818 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1