BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24691568 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18088
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 19, 2025
    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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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) AND ADJUSTED THE BLUE FIBER CABLES TO RESOLVE THE 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 FOUND TO COMMUNICATION ERRORS LEADING TO ERROR 40052. THE COMPLAINT WAS CONFIRMED BASED ON THE RESULTS OF THE INVESTIGATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TOWER DISPLAYED ERROR 40052 AND SHOWED A "ROBOT IS NOT CONNECTED OR POWERED ON" MESSAGE DURING THE INITIAL POWER UP. THE SITE PERFORMED AN EMERGENCY POWER OFF (EPO) PRIOR TO CALLING AND REPEATED THE EPO WHILE ON THE PHONE. THE ROBOT SHOWED IT WAS NOT CONNECTED TO THE TOWER, AND THE ROBOT INFORMATION WAS NOT FULLY DISPLAYED IN THE LOGS. THE BATTERY LED INDICATED A FULL CHARGE. THE SITE RESEATED THE CABLE, BUT THE ROBOT STILL DID NOT CONNECT, AND NO ERRORS WERE INITIALLY OBSERVED IN THE LOGS. THE CALLER NOTED THAT THE LED AT THE TOWER¿S BLUE FIBER CABLE CONNECTOR WAS NOT ILLUMINATED. THE TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CALLER THROUGH BLOWING ON THE CABLE ENDS AT BOTH THE TOWER AND ROBOT AND RESEATING THE CONNECTIONS, WHICH DID NOT RESOLVE THE ISSUE. THE CALLER REPLACED THE BLUE FIBER CABLE WITH A BACKUP, BUT THE ISSUE PERSISTED. THE TSE THEN INSTRUCTED THE CALLER TO MOVE THE BLUE FIBER CABLE FROM THE TOWER¿S TOP RIGHT CONNECTOR TO THE BOTTOM CENTER CONNECTOR, WHICH RESULTED IN ERROR 31089 APPEARING AND THE TOWER BLUE FIBER CONNECTOR LED BECOMING ILLUMINATED BLUE. THE PROCEDURE WAS ABORTED PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459529 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1