BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23760516 · Received December 9, 2025

    Report

    Report Number
    2955842-2025-47906
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 13, 2025
    Report Date
    January 9, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS ATTRIBUTED TO A PROGRAMMING ISSUE WITH THE VISION REAL-TIME CONTROLLER (VRTC) NODE IN THE VISION SIDE CART.

    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 WAS ABLE TO REPRODUCE THE ERROR. THE FSE REPROGRAMMED THE VISION TOWER COMMON COMPUTER CONTROLLER (CCC) TO ADDRESS THE ISSUE AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS INSPECTED, TESTED AND VERIFIED AS READY FOR USE.

    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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT A DATA COMMUNICATION LOSS WITH ERROR 7734. THE CUSTOMER STATED THAT THE SYSTEM SHUT DOWN AND THEY WERE ATTEMPTING TO BRING IT UP AT THE TIME OF THE CALL. THE SYSTEM POWERED ON, BUT A 40096 ERROR PRESENTED WHICH THE CUSTOMER COULD NOT CLEAR. THE CLINICAL SALES REPRESENTATIVE (CSR) ATTEMPTED A HARD POWER CYCLE ON THE SYSTEM, HOWEVER, THE 40096 ERROR RETURNED. THE TSE SUGGESTED ANOTHER HARD POWER CYCLE AND RESEATING ALL BLUE FIBER CABLES. THE CSR ATTEMPTED THE ACTION, BUT THE ERRORS PERSISTED. AS A RESULT, THE CUSTOMER CONVERTED TO LAPAROSCOPIC UNTIL THEY COULD BRING IN AND SETUP THEIR XI SYSTEM. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND IDENTIFIED ERROR 307 ALONG WITH A 311 GOLDEN IMAGE ERROR ON THE TOWER POINTING TO THE VISION REAL-TIME CONTROLLER (VRTC) - COMMON COMPUTER CONTROLLER (CCC). THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER CONFIRMED THE PROCEDURE WAS CONVERTED LAPAROSCOPICALLY. THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717913 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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