BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 21704712 · Received March 27, 2025

    Report

    Report Number
    2955842-2025-11773
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 THE MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE. 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 DEFECTIVE MTM. THE FSE REPLACED THE PART TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE SYSTEM LOGS, THE ERROR 23032 WAS FOUND DURING CALIBRATION CONFIRMING THE FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MASTER TOOL MANIPULATOR (MTM) WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE ERROR 23032 WAS FOUND TO BE FAILING ON THE AXIS 8 POINTING TO THE EMBEDDED SERIALIZER FOR MASTER HANDLE (ESMH). THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE CAN BE ATTRIBUTED TO A FAULT ON THE ESMH OF AXIS 8 WITHIN THE AFFECTED MTM. THIS ISSUE CAN BE RESOLVED BY SWITCHING TO A DIFFERENT SURGEON SIDE CONSOLE (SSC).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITH LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT TO REPORT THAT THE LEFT MASTER TOOL MANIPULATOR (MTML) WAS NOT RESPONDING TO THE COMMANDS MADE BY THE SURGEON. AFTER RESTARTING THE SYSTEM, ERROR 23032 WAS IDENTIFIED AND EVEN AFTER AN EMERGENCY POWER OFF (EPO), THE MESSAGE DID NOT DISAPPEAR. THE CUSTOMER COMPLETED THE PROCEDURE WITH RESTARTING THE SYSTEM WHENEVER THE MTML FAILED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE TSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL COMPLAINT INDICATED THAT THE MEDICAL TEAM RESTARTED THE SYSTEM WHENEVER THE MTM FAILED TO CONTINUE THE PROCEDURE. A RESTART/POWER CYCLE OF THE SYSTEM DID NOT RESOLVE THE REPORTED ISSUE DURING THE PROCEDURE. THE ROBOT STARTED NORMALLY AT 6:00, ONE PROCEDURE WAS UNEVENTFUL, IT REMAINED ON AND IN THE SECOND PROCEDURE, ALREADY STARTED, IT FAILED TO RECOGNIZE ARM 1 AND 2 (OPTICS) AS IF IT WAS NOT RELEASED TO THE SURGEON.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373907 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-10 N/A 00886874115374

    Patients

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