BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22834966 · Received August 18, 2025

    Report

    Report Number
    2955842-2025-34658
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 1, 2025
    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
    CO, US
    Reporter Occupation
    003

    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 WENT ON-SITE AND REPLACED THE MASTER TOOL MANIPULATOR (MTM) 2. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL INC. (ISI) RECEIVED THE MTM 2 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN LOGS, THE ERROR 1 WAS FOUND INDICATING POWER SUPPLY VOLTAGE OUT OF RANGE, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM2 WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR 1 WAS TRIGGERED INDICATING FAULT ON THE MTM, REPLICATING THE REPORTED EVENT. THE MTM2 WAS THEN INSTALLED ONTO THE PSC FIXTURE TEST PLATFORM (PFTP) WHERE POWER UP WAS FOUND TO BE FAILING. ONCE TESTING WAS COMPLETE THE ESMB PCA AND MAIN WIRE HARNESS WERE ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE FOR SENSOR ISSUES ON THE SURGEON SIDE CONSOLE (SSC) #2 CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND THE FIELD SERVICE ENGINEER (FSE) FIELD EVALUATION. THE SYSTEM FAILURE WAS RESOLVED BY PERFORMING TWO POWER CYCLES. FURTHERMORE, THE PROBABLE ROOT CAUSE OF MASTER TOOL MANIPULATOR (MTM) ISSUES ON SSC #1 IS ATTRIBUTED TO ELECTRICAL FAILURES ON THE EMBEDDED STERILIZER IN THE MASTER BASE (ESMB) BOARD AND MAIN WIRE HARNESS LOCATED ON MTM. THIS ISSUE CAN BE RESOLVED BY REPLACING THE MTM. THE SECTION D HAS BEEN UPDATED TO REFLECT THE CORRECT PRIMARY PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE SYSTEM WOULD NOT DEPLOY FOR DOCKING AND POWER CYCLE THE SYSTEM AND HAD NOT HEAR ¿READY FOR USE¿. THE REPORTER HARD POWER CYCLED THE SYSTEM WITH NO CHANGE. THE SYSTEM POWERED UP REFLECTING THE SSC HEAD SENSOR ON SSC1 WAS BLOCKED AND VERIFIED NOTHING WAS BLOCKING THE HEAD SENSOR. SITE SWAPPED OUT BOTH SSCS WITH ANOTHER SYSTEM SO THEY CAN CONTINUE WITH THE CASE. THE CONSOLE 2 KEY HAVING RIGHT ARM ISSUE AND CONSOLE 1 WAS HAVING SENSOR ISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS HAD BEEN PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. THE SYSTEM INITIALLY POWERED ON WITHOUT ANY ERRORS. THE TECH SUPPORT WAS CALLED FOR TROUBLESHOOTING AND UNSUCCESSFULLY DID MULTIPLE HARD RE-SETS, REMOVED THE CONSOLES FROM THE ROOM, BROUGHT IN A DIFFERENT SERIAL NUMBER'S CONSOLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194231 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A

    Patients

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