BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24580690 · Received March 12, 2026

    Report

    Report Number
    2955842-2026-15561
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 12, 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
    AS
    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) #1. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE USM #1 TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS COMPLETED, AND REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: -A 3 PHASE MOTOR DID NOT RESPOND AS EXPECTED ON THE USM #1, AXIS 6. (INCONSISTENT MOTOR CURRENT, VOLTAGE AND SPEED.) - FAULTY MOTOR, ENCODER, AMPLIFIER OR CONNECTION.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2 AND H11. CORRECTED SECTIONS: H6 AND H11. IT WAS CONFIRMED THAT THE PROCEDURE WAS ABORTED AS A RESULT OF THE SYSTEM FAULTS EXPERIENCED DURING THE CASE. THE CASE WAS NOT CONVERTED TO OPEN SURGERY AS NOTED ON THE INITIAL MDR.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, G3, G6, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) FOR FAILURE ANALYSIS EVALUATION. IN THE SYSTEM LOGS AN ERROR WAS FOUND INDICATING A FAULT ON THE DEGREE OF FREEDOM (DOF) 7, 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 THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE CARRIAGE FRICTION WAS FOUND TO BE FAILING ON THE DOF 7, REPLICATING THE REPORTED EVENT. ONCE TESTING WAS COMPLETED, THE DOF 7 STATOR WAS FURTHER TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) #1 WAS DISABLED DUE TO AN ERROR, WHICH INDICATED A FAILURE ON AXIS 6. ALTHOUGH THE SURGICAL TEAM INITIALLY PLANNED TO CONTINUE, THE PROCEDURE WAS ULTIMATELY ABORTED FOR UNSPECIFIED REASONS. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THE ERROR. TROUBLESHOOTING STEPS INCLUDED RESEATING THE STERILE ADAPTOR, USING A DIFFERENT INSTRUMENT ON USM #1, POWER CYCLING THE SYSTEM, AND REPLACING THE USM #1 DRAPE. DESPITE THESE EFFORTS, THE ERROR PERSISTED. THE TSE THEN ADVISED THAT USM #1 WOULD NEED TO BE REPLACED TO RESOLVE THE ISSUE. THE SURGEON ATTEMPTED TO PROCEED USING ONLY THREE USMS; HOWEVER, THE PROCEDURE WAS SUBSEQUENTLY ABORTED. IT WAS CONFIRMED THAT THE PROCEDURE WAS ABORTED AS A RESULT OF THE SYSTEM FAULTS EXPERIENCED DURING THE CASE. IT WAS LATER CONFIRMED THROUGH FOLLOW-UP INVESTIGATION THAT THE CASE WAS ACTUALLY CONVERTED TO OPEN SURGERY AS A RESULT OF THE SYSTEM FAULTS EXPERIENCED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594963 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1