BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24693722 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17939
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    June 5, 2024
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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 COMMON COMPUTE CONTROLLER (CCC) TO SOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE CCC WAS ANALYZED AND PLACED ON PCA CONFIGURATION EFT 722735-01 AND TESTED PER IPC 1069151-01 TO CONFIRM THE REPORTED PROBLEM SHOWING SYMPTOMS OF A "BRICKED" TEGRA MODULE. THE PROBLEM WAS CONFIRMED PER THE IPC INSTRUCTIONS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ALTHOUGH THE PROBLEM WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, THE SYSTEM WAS POWERING UP BUT NOT COMPLETING ITS HOMING SEQUENCE. THE ROBOT WAS SHOWING A MESSAGE STATING "SYSTEM CONNECTING, PLEASE WAIT FOR DA VINCI TO BE READY." THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CLINICAL SALES REPRESENTATIVE (CSR) HARD CYCLE THE ROBOT. THE ROBOT STARTED GOING THROUGH ITS HOMING SEQUENCE AND THEN STOPPED WITH THE SAME MESSAGE. THE TSE HAD THE CSR CHECK THE CONSOLE, ENSURING IT COMPLETED ITS PORTION OF THE HOMING SEQUENCE. THE TSE HAD CSR THEN PERFORM A HARD CYCLE ON THE TOWER AND ROBOT, BUT THE MESSAGE PERSISTED. THE TSE HAD THE CSR REPLACE THE BLUE FIBER CABLE GOING FROM THE TOWER TO THE ROBOT AND STILL THERE WAS NO CHANGE. AT THIS POINT, THE CUSTOMER WANTED TO MOVE FORWARD WITH THEIR CASE AND OPTED TO BRING IN THEIR DA VINCI XI SYSTEM. THE PROCEDURE WAS ABORTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THEY ABORTED TO ANOTHER DA VINCI SYSTEM PRIOR TO PORT PLACEMENT. THE PATIENT HAD NOT YET ENTERED THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539775 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1