BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22879342 · Received August 22, 2025

    Report

    Report Number
    2955842-2025-35468
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE UNIT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. 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 UNIVERSAL SURGICAL MANIPULATOR (USM) 3 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN LOG REVIEWS, 1162 AC MAGNETIC CANNULA SENSOR FAULT REPORTED BY THE AXES CONTROLLER BOARD (ACS) BOARD, CONFIRMING THE FAULT OCCURRED THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE AXES CONTROLLER SPAR CONNECTOR (ACSC) PRINTED CIRCUIT ASSEMBLY (PCA) WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. WHILE FAILURE ANALYSIS COULD NOT REPLICATE THE REPORTED ISSUE, THE ERROR 1162 IDENTIFIED IN THE SYSTEM LOGS SUGGEST THE ROOT CAUSE IS ATTRIBUTED TO A FAULT WITH THE ACSC BOARD. THIS ISSUE CAN BE RESOLVED BY FSE REPLACEMENT OF THE USM. CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA BILATERAL SURGICAL PROCEDURE, THAT A RECOVERABLE ERROR 1162 WAS REPEATEDLY OCCURRING, RELATED TO THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM 3), INDICATING A MAGNETIC CANNULA SENSOR FAILURE. THE CUSTOMER HAD POWER CYCLED THE SYSTEM SEVERAL TIMES, BUT THE ERROR PERSISTED. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SERVICE ENGINEER (TSE). TSE SUGGESTED TO DISABLE THE USM3, AND THE CUSTOMER NOTED THAT THEY MIGHT NOT BE ABLE TO USE THE SYSTEM FOR THE NEXT SURGICAL PROCEDURE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE CUSTOMER, A NEW PATIENT SIDE CART (PSC) WAS BROUGHT INTO THE OPERATING ROOM. THERE WAS A SURGICAL DELAY OF 15 TO 30 MINUTES.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495603 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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