BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23304700 · Received October 15, 2025

    Report

    Report Number
    2955842-2025-41797
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 23, 2025
    Report Date
    January 12, 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
    SZ
    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 REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE USM FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN LOGS, THE 282 ERROR WAS FOUND INDICATING TOOL AND MAGNET NOT DETECTED, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, RUST WAS FOUND ON THE GEARBOX WHICH COULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE INSTRUMENTS WOULD NOT ENGAGE, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ON AN IN-HOUSE PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE THE UNIT FAILED THE CARRIAGE SWITCHES TEST. A KNOWN GOOD AXES CONTROLLER CARRIAGE INTERFACE (ACCI) BOARD WAS INSTALLED, AND THE UNIT PASSED THE REQUIRED TEST, VERIFYING THE ACCI TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE ROOT CAUSE IS ATTRIBUTED TO A FAULTY ACCI BOARD IN THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) REP. CONTACTED ISI TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 4 DID NOT RECOGNIZE ANY INSTRUMENTS PRIOR TO A SCHEDULED PROCEDURE. INITIAL TROUBLESHOOTING INVOLVED TRYING TWO DIFFERENT STERILE ADAPTERS (SA)S, CHECKING SYSTEM LOGS WHICH REVEALED ERROR #282 INDICATING INSTRUMENT RECOGNITION FAILURE DUE TO UNDETECTED TOOL SENSORS, AND INSPECTING THE UNIT FOR DISC AND POGO PIN MOVEMENT. DESPITE APPEARING NORMAL, THE DISCS DID NOT SPIN PROPERLY WHEN A SA WAS INSERTED. ADDITIONAL ATTEMPTS WITH ANOTHER SA AND POWER CYCLING THE PATIENT SIDE CART (PSC) WITH CIRCUIT BREAKER (CB) AND EMERGENCY POWER OFF (EPO) ALSO FAILED TO RESOLVE THE ISSUE. FURTHER TROUBLESHOOTING INVOLVED TRYING ANOTHER INSTRUMENT ON ARM 4, WHICH REMAINED UNRECOGNIZED, ALTHOUGH IT WORKED FINE ON A DIFFERENT ARM. NO ADDITIONAL PROCEDURE DETAILS WERE OBTAINED AT THAT TIME. LATER, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AS PLANNED USING THREE ARMS. 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
    2288599 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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