BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24510531 · Received March 4, 2026

    Report

    Report Number
    2955842-2026-14950
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 6, 2026
    Report Date
    April 15, 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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTAL SETUP JOINT (SUJ) HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS. UPON VISUAL INSPECTION, ALL SETUP FIELD REPLACEMENT UNIT LOWER (SFL) PINS WERE MISSING AND THE J11 CONNECTOR WAS BROKEN THUS CONFIRMING AND REPLICATING THE REPORTED EVENT. INSTALLED GOLDEN SFL PRIOR TESTING. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM IN NORMAL MODE WHERE IT FUNCTIONED AS EXPECTED. THE UNIT WAS THEN INSTALLED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL RELEVANT TESTS WITHOUT ANY LOG ERRORS. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE SFL PRINTED CIRCUIT ASSEMBLY (PCA) WAS THE ROOT CAUSE OF THE REPORTED PROBLEM. THE PROXIMAL SUJ HAS BEEN EVALUATED BY THE FA. FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM IN NORMAL MODE WHERE IT TRIGGERED ERROR 26002 INDICATING BEHAVIOR PRIMITIVE (BP) MIDDLEMAN FAULT AND ERROR 307 INDICATING NODE WAS NOT PRESENT AFTER STARTUP THUS CONFIRMING AND REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ON A PFTP WHERE IT FAILED EEPROM ENCODER TESTS. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE AXES CONTROLLER SETUP (ACU) PCA IS CONSISTENT WITH THE REPORTED PROBLEM AND CONSIDERED THE POTENTIAL ROOT CAUSE. THE UNIVERSAL SURGICAL MANIPULATOR (USM) HAS BEEN EVALUATED BY THE FA. FA WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE UNIT WAS THEN INSTALLED ONTO A PFTP WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, ALL SEARCHLIGHT, CHIPENCODER VIRTUAL ABSOLUTE (CVA), AND HALL SENSOR ASSEMBLIES WERE INSPECTED, BUT NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FA CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE DISTAL SETUP JOINT (SUJ), THE PROXIMAL SUJ, AND THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE DISTAL SUJ INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. AS OF THE DATE OF THIS REPORT, THE PROXIMAL SUJ AND THE USM HAVE NOT YET BEEN RECEIVED BY ISI FOR EVALUATION.

    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 DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE REPORTED TO TECHNICAL SUPPORT THAT ERROR 319 AND ERROR 26002 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE CUSTOMER POWER CYCLED THE SYSTEM, BUT THAT DID NOT RESOLVE THE ISSUE. THE PROCEDURE CONTINUED AS PLANNED USING THREE ARMS, WITH NO KNOWN IMPACT OR PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330428 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 NA 00886874110720

    Patients

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