BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24554801 · Received March 10, 2026

    Report

    Report Number
    2955842-2026-15454
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    April 24, 2025
    Report Date
    March 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
    UT, US
    Reporter Occupation
    NURSE
    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 FIBER OPTIC CABLE (FOC) TO RESOLVE ERRORS 40074, 40068, AND 31089. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS NOT RECEIVED THE FOC FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT WHILE SETTING UP FOR THE CASE TO REPORT AN ERROR KEEPS POPPING UP ON THE SYSTEM WHEN POWERING IT ON. THE CALLER STATED THEY HAVE REBOOTED THE SYSTEM 4 TIMES AND THE ERROR RETURNS EACH TIME. THE TSE TRIED TO VIEW SYSTEM LOGS AND SETUP BUT LOGS FROM TODAY WEREN'T LOADING. THE CALLER STATED THEY GET A MESSAGE ON THE SCREEN TO RESTART AND ERROR 40074/40068. THE TSE RECOMMENDED TRYING A HARD REBOOT ON THE SYSTEM. THE CALLER PERFORMED A HARD REBOOT ON THE SYSTEM AND WHEN IT POWERED BACK ON THEY GOT AN ERROR 17. THE TSE RECOMMENDED REBOOTING AND RESEATING AND CLEANING THE BLUE FIBER CABLES. THE CALLER STATED THEY CHECKED THE BLUE FIBER CABLE CONNECTIONS, AND THEY WERE ALL CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90871 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1