BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24636108 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16762
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 21, 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
    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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). 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. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS DID REPLICATE AND CONFIRM THE CUSTOMER COMPLAINT ERROR (B)(4). IN LOGS, THE 31009 AND 22037 ERRORS WERE FOUND INDICATING INSTRUMENT SENSORS MISSING. A TOOL WAS FULLY DETECTED BUT THEN LOST 1 OR MORE BUT NOT ALL OF THE TOOL SENSORS FOR 3+ SECONDS AND LOG_HIGH_VARIANCE_ENCODER ON THE UNIVERSAL SURGICAL MANIPULATOR (USM), CONFIRMING THE FAULT 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 WHERE THE 31009 ERROR WAS TRIGGERED INDICATING FAULT ON THE CARRIAGE. THE UNIT WAS THEN INSTALLED ONTO A PATIENT FIXTURE TEST PLATFORM WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE CARRIAGE WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE AXES CONTROLLER CARRIAGE INSTRUMENT BOARD (ACCI) ASSEMBLY AND PRESENCE PINS WERE FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DUODENAL SWITCH SURGICAL PROCEDURE USING AN XI SYSTEM, THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 3 DID NOT INITIALLY RECOGNIZE THE STERILE ADAPTER (SA) OR INSTRUMENT. THE SITE REPLACED THE SA, BUT THE ISSUE PERSISTED. AFTER PERFORMING A POWER CYCLE, THE SYSTEM BEGAN READING INSTRUMENTS AND THE SA WITHOUT ANY ISSUES, AND THE SITE PROCEEDED WITH THE CASE. LATER, AN OPERATING ROOM (OR) STAFF CONTACTED TECHNICAL SUPPORT AGAIN AFTER THE PROCEDURE, REPORTING THAT THE SITE HAD TO SHUT DOWN THE SYSTEM MULTIPLE TIMES. THE CALLER STATED THAT A REBOOT WAS REQUIRED FOR EACH INSTRUMENT SWAP ON ARM 3 DUE TO DRAPE ERROR MESSAGES. REPLACING THE DRAPE DID NOT RESOLVE THE ISSUE, AND INSPECTION OF THE ARM SENSING PINS REVEALED NO PROBLEMS. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. THE CALLER NOTED THAT THE SITE PLANNED TO USE THE CAMERA IN ARM 3 TO MINIMIZE INSTRUMENT EXCHANGES FOR THE FOLLOWING PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150064 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A 00886874110720

    Patients

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