BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23423425 · Received October 30, 2025

    Report

    Report Number
    2955842-2025-41827
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 8, 2025
    Report Date
    May 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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) #4 AND SET UP JOINT (SUJ) #4, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS WAS PERFORMED, AND THE INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED ERRORS: - AURORA LINK ERROR REPORTED BY UNIVERSAL MOTION CONTROLLER (UMC2), CHECK DOWNSTREAM LINK TO SUJ4 AXES CONTROLLER SETUP (ACU4), PORT: 2 (AURORA COMM CYCLIC REDUNDANCY CHECK (CRC) ERROR, ERROR COUNT:4) - AURORA COMMUNICATION LINK ERROR REPORTED BY ACU ON ARMNET4 IN SUJ PROXIMAL (XI) OR ACJ (X) (UPSTREAM COMM. LINK TO UMC). - MOTOR AXIS MESSAGE (MAXM) IS LATE OR MISSING ON ARM 4, FROM XI: AXES CONTROLLER ARM (ACA) (USM) / X: AXES CONTROLLER, MOTOR (ACM) (USM) - UNIVERSAL ENERGY CONTROLLER (UCE4) ON UMC2 RECEIVED AN INCONSISTENT MAXM COUNT ON ACA - MAXM RECEIVED WITH SEQUENCE NUMBER INCONSISTENT WITH PREVIOUS MESSAGE ON ARM 4, XI: ACA (USM) / X: ACM (USM).

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, G3, G6, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE UNIVERSAL SURGICAL MANIPULATOR (USM) #4, BUT DID RECEIVE THE PROXIMAL SET UP JOINT (SUJ) FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF THE SYSTEM LOGS CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE PROXIMAL SUJ WAS INSTALLED ONTO A TEST SYSTEM WHERE ERRORS WERE OBSERVED ON STARTUP, REPLICATING THE REPORTED EVENT. FURTHER TESTING OF THE PROXIMAL SUJ ON THE TEST PLATFORM REVEALED THAT MISSING NODES. TESTING OF THE FIBER OPTIC CABLE IDENTIFIED IT AS THE SOURCE OF THE FAULT. AFTER TESTING, A VISUAL INSPECTION FOUND NO ADDITIONAL FAULTS RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, REQUIRING CONVERSION TO A LAPAROSCOPIC APPROACH AND PLACEMENT OF AN ADDITIONAL PORT. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) WAS CONSULTED AND VERIFIED THE ERRORS, WHICH INDICATED A COMMUNICATION ISSUE BETWEEN THE DOWNSTREAM UNIVERSAL MOTION CONTROLLER (UMC2) AND AXES CONTROLLER SETUP (ACU) FOR UNIVERSAL SURGICAL MANIPULATOR (USM) #4. AS A RESULT, THE PATIENT SIDE CART (PSC) BECAME UNRESPONSIVE EXCEPT FOR THE ABILITY TO PERFORM A SYSTEM POWER CYCLE. A POWER CYCLE WAS PERFORMED, BUT THE ERROR OCCURRED AGAIN. THE PSC WAS UNDOCKED FROM THE PATIENT AND SWITCHED TO MANUAL MODE DUE TO CONTINUED UNRESPONSIVENESS. A FINAL POWER CYCLE ATTEMPT RESULTED IN ADDITIONAL ERRORS, INDICATING A FAULT WITH USM #4. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC APPROACH, AND AN ADDITIONAL PORT WAS PLACED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14930 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-58 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1