BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24825021 · Received April 9, 2026

    Report

    Report Number
    2955842-2026-20942
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). IN THE SYSTEM LOGS, ERRORS 31089, 170, 307 WERE FOUND 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 ROBOT COMMON COMPUTE CONTROLLER (CCC) WAS INSTALLED IN THE KNOWN GOOD SYSTEM, WHICH TRIGGERED THE REPORTED ERROR INDICATING FAULTS ON THE FIREFLY FIBER OPTIC CABLE (FF3) CONNECTED TO THE ROBOT CCC. THE FF3 WAS REPLACED WITH A KNOWN GOOD CABLE, AFTER WHICH THE ROBOT CCC FUNCTIONED AS EXPECTED. HOWEVER, WHEN THE ORIGINAL FF3 WAS REINSTALLED, THE FAULT REOCCURRED. ADDITIONALLY, THE SYSTEM WAS UNABLE TO PROGRAM THE COMMON COMPUTE ENGINE NODE DURING THE PROGRAMMING PROCESS. THIS ISSUE WAS DETERMINED TO BE CAUSED BY A FAULT IN THE COMMON COMPUTE ENGINE NODE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE IS ATTRIBUTED TO A BAD FF3 IN THE ROBOT CCC. THIS ISSUE MAY BE RESOLVED BY FSE SERVICE OF THE SYSTEM TO REPLACE THE ROBOT CCC.

    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 ASKED THE ROBOTICS COORDINATOR IF THEY COULD POWER OFF THE SYSTEM, USE ONE OF THE BLUE FIBER CABLES THAT THEY KNEW WORKED FROM THE NORMAL-FUNCTIONING CONSOLES, AND PLUG IT INTO THE ROBOT TO CONFIRM IT FUNCTIONED WITH A NEW CABLE, BUT THEY WERE UNABLE TO PERFORM THE TROUBLESHOOTING INSTRUCTIONS. THE CLINICAL SALES REPRESENTATIVE (CSR) RETRIEVED AN EXTRA BLUE FIBER CABLE FROM ANOTHER SITE. THE CSR REPLACED THE ROBOT BLUE FIBER CABLE WITH A NEW ONE, BUT THE ISSUE DID NOT RESOLVE. THE MESSAGE ON THE ROBOT INDICATED THAT IT WAS NOT COMMUNICATING WITH THE SYSTEM. THE FSE THEN HAD THE CSR POWER OFF THE SYSTEM AND CONNECT THE NEW BLUE FIBER CABLE INTO A KNOWN WORKING PORT ON THE TOWER FOR ONE OF THE CONSOLES AND CONNECT THE ROBOT, BUT THE ISSUE DID NOT RESOLVE. THE FSE DETERMINED THAT A NEW FIBER CABLE AND A NEW PORT ON THE TOWER TO THE ROBOT WOULD NOT RESOLVE THE ISSUE. THE FSE BELIEVED THE ISSUE RESIDED ON THE ROBOT WITH EITHER THE COMMON COMPUTE CONTROLLER, INTERNAL BLUE FIBER PIGTAIL OR BLUE FIBER PORT. THE FSE FOUND 41006, 307, AND 41107 FAULTS ON THE ROBOT UPON STARTUP. THE PSC HAD THE FAULTS. THE FSE REPLACED THE ROBOT CCC. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    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 STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN 31089 ERROR AND THE SITE SAID THEY HAD THE SYSTEM CONNECTED WITH WALL PLATES. THE BLUE CABLE AT THE ROBOT WAS NOT LIGHTING UP AND THE CALLER SAID THE CABLE WENT TO A WALL PLATE AND THEY COULD NOT UNPLUG IT AS IT WAS HARD WIRED INTO THE WALL PLATE. THEY DID NOT HAVE ANY OTHER CABLE TO USE. THEY WERE NOT AWARE OF ANY OTHER BLUE CABLE THEY COULD USE TO BYPASS THE WALL PLATES AND CONNECT THE ROBOT TO THE TOWER DIRECTLY. IT WAS CONCLUDED THAT THE SYSTEM WAS IN A DOWN STATE. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21765 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1