BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25197081 · Received May 18, 2026

    Report

    Report Number
    2955842-2026-25387
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 15, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROBOT COMMON COMPUTE CONTROLLER (CCC) WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERRORS AT STARTUP WERE CONFIRMED AND REPLICATED. IN THE FIELD SYSTEM LOGS, ERRORS 31089, 170, AND 307 WERE FOUND TO INDICATE THAT THE FAULT HAD OCCURRED THE FIELD. UPON VISUAL INSPECTION, NO ISSUE WAS FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD SYSTEM. THE GOLDEN SYSTEM WAS SET TO RUN 10 POWER CYCLES AND SIT IDLE FOR FOUR DAYS. THEN, SYSTEM KEPT FAULTING OUT WITH ERRORS 31089, 170, AND 307. THE FIREFLY OPTIC CABLE ON THE CCC WAS REPLACED WITH A KNOWN-GOOD CABLE FOLLOWING THE AB PROCEDURE. AFTER REPLACEMENT, THE CCC OPERATED AS EXPECTED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE A BAD FIREFLY OPTIC CABLE (FF3) IN THE ROBOT CCC.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED THE COMMON COMPUTE CONTROLLER (CCC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, CUSTOMER SITE CALLED TO REPORT THAT THEY ARE RECEIVING AN ERROR 41107 AT STARTUP, THEN ERROR 31030. THERE IS ALSO A MESSAGE THAT THE ROBOT IS NOT CONNECTED TO THE TOWER ALTHOUGH THE ARMS ARE BLUE ALONG WITH THE POWER BUTTON ON THE ROBOT. TECHNICAL SUPPORT ENGINEER (TSE) HAD CUSTOMER HARD POWER CYCLE THE ENTIRE SYSTEM BUT THE SAME ERRORS CAME UP UPON RESTART. CUSTOMER NOTICED THAT ONE OF LEDS ON THE TOWER WHERE THE BLUE FIBER CABLES PLUG IN WAS NOT ILLUMINATED. TSE HAD CUSTOMER POWER SYSTEM DOWN AND MOVE THE BLUE FIBER CABLE TO THE EMPTY SLOT ON THE TOWER. THE SYSTEM RESTARTED WITH THE MESSAGE THAT THE BOOM AND CART DRIVES WERE DISABLED AND THE LEDS ON THE ARMS WERE NOT ILLUMINATED. SITE IS MOVING CASE TO XI SYSTEM IN OTHER OR. TSE LOG REVIEW SHOWS 31089 ERROR REPORTING BETWEEN TOWER AND EQUIPMENT ATTACHED AT FIBER PORT ONE. THE PROCEDURE WAS ABORTED TO ANOTHER PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CASE WAS COMPLETED ROBOTICALLY. THERE WAS NO HARM TO THE PATIENT. THERE WAS A 38 MIN. DELAY DUE TO THE ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528603 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-45 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1