BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22626783 · Received July 28, 2025

    Report

    Report Number
    2955842-2025-31811
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 4, 2025
    Report Date
    July 9, 2025
    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
    CA, US
    Reporter Occupation
    003

    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 WENT ON-SITE AND REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HSRV) AND ENDOSCOPE CONTROLLER (EC). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE ENDOSCOPE CONTROLLER (EC) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND UPON VISUAL INSPECTION, FOUND DCIB METAL PLATE IS LIFTED AND DAMAGED WHICH WAS CAUSING THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE SYSTEM DID NOT PRESENT ANY ERRORS WHEN INITIALLY POWERED ON. THE SYSTEM WAS POWER CYCLED TO RESOLVE THE ISSUE. THE ORIGINAL SURGEON SIDE CONSOLE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND UPON VISUAL INSPECTION NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. TESTING: THE MONITOR WAS INSTALLED ON OUR PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND NOT TINTED. THE SYSTEM IDLED FOR 1 HOUR AND VISUALLY VERIFIED THAT THERE WERE NO ISSUES. THE ROOT CAUSE IS ATTRIBUTED TO A DAMAGED DCIB CAUSING A FAILURE IN THE VIDEO ACQUISITION PROCESS WITHIN THE ENDOSCOPE CONTROLLER. CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE LEFT EYE OF THE HIGH-RESOLUTION STEREO VIEWER REPEATEDLY WENT BLACK. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

    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.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508431 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-16 N/A 00886874110744

    Patients

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