BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24622209 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16459
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 22, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND IN THE SYSTEM LOGS, THE 23003 ERROR WAS FOUND INDICATING JOINT POSITION ERROR LIMIT FOR MASTER TOOL MANIPULATOR (MTM) AND PATIENT SIDE MANIPULATOR (PSM) COUPLED WITH ERROR 23007 INDICATING HIGH COMMAND VELOCITY DURING WIGGLE TEST ON THE USM YAW AXIS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, ALL SEARCHLIGHT, CHIPENCODER VIRTUAL ABSOLUTE (CVA), AND HALL SENSOR ASSEMBLIES WERE INSPECTED, BUT NO FAULTS COULD BE IDENTIFIED. THE COMPLAINT REGARDING UNABLE TO ADVANCE USM WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO CORRECT THE REPORTED EVENT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    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 SURGICAL PROCEDURE THAT THE CUSTOMER WAS UNABLE TO ADVANCE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE STAFF TRIED MULTIPLE INSTRUMENTS AND RESEATING THE DRAPE, WITH NO CHANGE. THE CUSTOMER PROCEEDED WITH THREE USMS. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417519 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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