BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23614051 · Received November 21, 2025

    Report

    Report Number
    2955842-2025-45865
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 30, 2025
    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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE COMPONENT WAS ANALYZED AND IT WAS FOUND TO HAVE AN ERROR 32097 INDICATING THAT MAXIS ERROR HAD OCCURRED, ON AXES CONTROLLER MOTOR (ACM) FOLLOWED BY 1126 ERROR. THE HIROSE FIBER RECEIVED A MESSAGE STATING THAT POWER HAD FALLEN BELOW THE LOW WARNING LIMIT. THE SYMPTOMS WERE BEING SEEN ON AXES CONTROLLER ARM (ACA), AXES CONTROLLER MOTOR (ACM) AND AXES CONTROLLER SPAR (ACS) BOARDS, CONFIRMING THE FAULT HAD OCCURRED IN THE FIELD. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE FIBER TEST WAS FOUND TO BE FAILING ON CLOCK SPRING, PARALLELOGRAM AND ROLLING LOOP FIBERS. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE CAN BE ATTRIBUTED TO A COMMUNICATION FAULT AMONG THE FIBERS ASSEMBLY (CLOCK SPRING, PARALLELOGRAM AND ROLLING LOOP) WITHIN THE AFFECTED USM.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE TRANS VESICAL PROSTATECTOMY SURGICAL PROCEDURE THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS DISABLED AND COULD NOT BE MOVED. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) VERIFIED THAT ERROR 32097 OCCURRED AGAINST USM 3 AND THAT THE CUSTOMER HAD DISABLED IT. THE TSE WALKED THE CALLER THROUGH A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO). THE SYSTEM POWERED UP WITHOUT ERRORS, BUT THE TSE ADVISED THAT DUE TO THE FREQUENCY OF THE ERROR THAT THE ERROR WOULD MOST LIKELY COME BACK. THE CUSTOMER CONTINUED WITH THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346572 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

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