BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23385582 · Received October 24, 2025

    Report

    Report Number
    2955842-2025-42807
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 13, 2025
    Report Date
    February 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED AND DURING VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WERE RELATED TO THE REPORTED ISSUE. THE UNIT WAS THEN INSTALLED IN AN IN-HOUSE SYSTEM WHERE DURING PROGRAMMING, THE SURGEON CONSOLE LEAF (SCL) SLOT 1 LEAF WAS FOUND MISSING, UPON START UP ERROR 48200 WAS REPLICATED. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE ROOT CAUSE IS ATTRIBUTED TO A FAULTY SCL BOARD WITHIN THE PMSC, WHICH WAS NOT DETECTED BY THE SYSTEM AND CAUSING ERROR 48200 TO BE TRIGGERED. THE BOARD IS EXPECTED TO PROCESS COMMANDS AND DATA FROM THE SSC TO PROVIDE THE VIDEO OUTPUT TO THE HIGH RESOLUTION STEREO VIEWER (HRSV). THIS ISSUE CAN BE RESOLVED BY REPLACING THE COMPONENT.

    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 PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE PMSC.

    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 RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, A NURSE CALLED AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THEIR SECOND CONSOLE, WHICH WAS NOT ACTIVELY IN USE, HAD ONE EYE BLACK. THE TSE CHECKED THE LOGS AND IDENTIFIED ERROR 48200 POINTING TO PERSONALITY MODULE SURGEON CONSOLE (PMSC) SLOT 3. THE TSE SUGGESTED A SYSTEM REBOOT, BUT DUE TO THE ONGOING SURGERY, IT WAS AGREED TO HAVE A CALLBACK AFTER THE SURGERY FOR FURTHER TROUBLESHOOTING. AFTER THE SURGERY ENDED, THE NURSE AND SURGEON CALLED BACK, AND IT WAS NOTED THAT A REBOOT HAD NOT BEEN SUCCESSFUL. THE TSE ASKED THEM TO CLEAN AND RESEAT THE BLUE FIBER CABLE TO SURGEON SIDE CONSOLE (SSC2). UPON BOOTING, THE LEFT MONITOR SHOWED THE BOOT-UP SCREEN BUT THEN TURNED BLACK. THERE WERE NO EXTERNAL CONNECTIONS TO THE SSC, AND THE SURGEON CONNECTED THE SIMULATOR WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY. THE ISSUE DID NOT CAUSE ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790280 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-27 N/A 00886874110744

    Patients

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