BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24299488 · Received February 9, 2026

    Report

    Report Number
    2955842-2026-03718
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 28, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2023-07-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT YET RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE AND WAS RESOLVED BY REPLACEMENT OF THE USM.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE LOGS, THE ¿25734¿ ERROR WAS FOUND INDICATING ¿MAXM (MOTOR AXIS MESSAGE): BAD CHECKSUM ON ARM 2¿, CONFIRMING THE FAULT OCCURRED IN THE FIELD. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS INSTALLED ONTO A TEST PLATFORM WHERE ¿PITCH SPEED LOW TEST¿ WAS FOUND TO BE FAILING ON THE PITCH. ONCE TESTING WAS COMPLETED, THE ¿PITCH MOTOR MODULE¿ WAS FURTHER INSPECTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE OF THE PITCH MOTOR MODULE ASSEMBLY WITHIN THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM PRESENTED RECOVERABLE ERROR 25734 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THIS ERROR WAS RECOVERED, BUT THE ERROR WAS STILL PRESENT. AS THE PROCEDURE WAS ALREADY NEARING COMPLETION, THE SURGEON DECIDED TO FINISH THE PROCEDURE LAPAROSCOPICALLY. THE TECHNICAL SERVICE ENGINEER (TSE) CHECKED THE SYSTEM EVENT LOGS AND IDENTIFIED THE FAILURE RECORD. THE TSE INSTRUCTED THE CUSTOMER TO SHUT DOWN THE SYSTEM, PERFORM AN EMERGENCY POWER OFF (EPO), AND RESTART THE SYSTEM. AFTER THIS ACTION, THE SYSTEM DID NOT PRESENT THE FAILURE AND IS CLEARED FOR USE. HOWEVER, THE TSE CHECKED THE LOGS AND IDENTIFIED THAT A VISIT TO INSPECT THE SYSTEM WILL BE NECESSARY, AS THIS FAILURE INDICATES A PROBLEM WITH THE USM2. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INCREASE IN INCISION. THERE WERE NO ADDITIONAL PORTS PLACED. THE SYSTEM INITIALLY STARTED UP WITHOUT ERRORS, INITIAL TESTS VALIDATED. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY, WITHOUT COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE POST-PROCEDURE RECOVERY ROOM, CONSCIOUS AND ALERT, WITH NO COMPLAINTS, AND DISCHARGED FROM HOSPITAL FOR OUTPATIENT FOLLOW-UP WITH ATTENDING PHYSICIAN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116609 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-45 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES