BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21145973 · Received January 13, 2025

    Report

    Report Number
    2955842-2025-00378
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 17, 2024
    Report Date
    December 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    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. THE FSE REPLACED THE TOUCHPAD TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. A REVIEW OF THE SITE¿S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE INTUITIVE SURGICAL, INC. (ISI) QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 25730 INDICATING MOTOR AXIS MESSAGE IS LATE OR MISSING ON THE GANTRY, FROM ACP4 (SHOULDER/BOOM); 32114 INDICATING AURORA COMMUNICATION LINK ERROR REPORTED BY ACP3 (DOWNSTREAM COMM. LINK TO ACP4); 32097 INDICATING MAXIS ERROR OCCURRED, REPORTED BY ACP5 (OP) PLOOP MACM BRAKE COMMAND WATCHDOG (MISSING MESSAGE) ERROR; 40106 INDICATING AN INTERRUPT STATUS REGISTER IN UCE5 ON UMC2 IN THE PSC REPORTED THAT AN INTERRUPT WAS PRESENT WHEN NOT EXPECTED AND 307 INDICATING NODE NOT PRESENT: TPC1 IN SSC1 TOUCHPAD A NODE CONFIGURED TO BE PRESENT HAS STOPPED RESPONDING. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DEFECTIVE TOUCHPAD. ISI PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE PATIENT CART WAS USED, AND THE CUSTOMER DROVE THE PATIENT CART INTO POSITION, DISABLED THE MOTOR DRIVE SO THE BOOM COULDN'T BE USED BUT THIS DID NOT AFFECT THE ARM MOTORS TO DOCK AND COMPLETE THE CASE. AFTER THE CASE THE PATIENT CART WAS CHANGED FOR ANOTHER. THE PROCEDURE STARTED AS A DUAL CONSOLE SYSTEM AND THE SITE BELIEVES THAT IT ENDED AS A DUAL CONSOLE SYSTEM. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE PATIENT CART HAVING THE ISSUE, ONCE THEY DISABLED THE MOTOR DRIVE, THEY COULDN'T MOVE THE BOOM, BUT THE CASE WAS ABLE TO BE COMPLETED. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT WAS CONTACTED AND WALKED THE TEAM THROUGH THE SOLUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON CALLED TO REPORT A NON-RECOVERABLE FAULT. TECHNICAL SERVICE ENGINEER (TSE) VIEWED LIVE LOGS AND FOUND ERRORS 25730, 32114, 32097, AND 40106 ON THE PATIENT SIDE CART (PSC). THE TSE ASKED THE SURGEON TO USE THE INSTRUMENT RELEASE KIT (IRK) TO RELEASE TISSUE FROM THE INSTRUMENTS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE TSE ASKED THE SURGEON TO POWER CYCLE SYSTEM. SYSTEM POWERED AND HOMED SUCCESSFULLY, BUT THE SYSTEM WAS FAULTING WITH NON-RECOVERABLE FAULT. TSE VIEWED LIVE LOGS, FOUND ERROR 307 POINTING TO SURGEON SIDE CONSOLE (SSC) TOUCHPAD. TSE REQUESTED FOR THE CUSTOMER TO POWER CYCLE THE SYSTEM AND DISCONNECT THE BLUE FIBER CABLE FROM SSC 1. THE SYSTEM POWERED AND HOMED SUCCESSFULLY, AND DA VINCI SYSTEM WAS READY. THE SYSTEM POWERED IN SINGLE SURGEON CONSOLE CONFIGURATION. THE PATIENT SIDE ASSISTANT RE-INSTALLED INSTRUMENTS. THE SURGEON WAS CONTINUING WITH PROCEDURE ROBOTICALLY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515895 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A

    Patients

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