BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22778523 · Received August 11, 2025

    Report

    Report Number
    2955842-2025-33732
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 22, 2025
    Report Date
    July 22, 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
    NY, US
    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 WENT ON-SITE AND INSPECTED THE FOOT SENSOR AND FOUND THE LEFT SENSOR GREEN LED NOT WORKING AND THE FAN WAS LOUD. THE FSE REPLACED THE FOOTREST PEDAL AND THE REDUNDANT MEDICAL GRADE POWER SUPPLY (MGPS). THE SYSTEM WAS VERIFIED AND READY FOR USE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE REDUNDANT MEDICAL GRADE POWER SUPPLY (MGPS) FOR FAILURE ANALYSIS INVESTIGATION. THE MGPS WAS ANALYZED, AND THE FOLLOWING OBSERVATIONS WERE MADE: MGPS: THE MGPS WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED NOISE COMPLAINT WAS CONFIRMED. IN LOG REVIEWS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED THE FIELD. UPON VISUAL INSPECTION THE FAN LOOKED DUSTY. THE POWER SUPPLY WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE RMGP POWER SUPPLY STARTED MAKING AN ABNORMAL NOISE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OPERATING ROOM (OR) STAFF CONTACTED TECHNICAL SUPPORT REGARDING A "FOOT POSITION SENSOR BLOCKED" MESSAGE. THE ISSUE WAS REPORTED TO INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT AFTER COMPLETING THE PROCEDURE. AT THE TIME OF THE CALL, LOGS WERE UNAVAILABLE. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED CLEANING THE FOOT POSITION SENSOR COVERS, BUT THE CUSTOMER REPORTED THAT THIS DID NOT RESOLVE THE ISSUE. THEY ALREADY DISCONNECTED THE SECOND SURGEON SIDE CONSOLE (SSC) AND REQUESTED THE FIELD ENGINEER TO FOLLOW UP TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006970 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