BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25238110 · Received May 21, 2026

    Report

    Report Number
    2955842-2026-25875
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 ENDOSCOPE CONTROLLER (EC) DUE TO ERROR 45312. THE PREVIOUS EC THAT WAS INSTALLED ON (B)(6) 2026 WAS THOUGHT TO BE DOA. FSE REQUESTED THAT THE HOSPITAL LEAVE AN ENDOSCOPE IN THE ROOM TO ASSIST WITH THE VERIFICATION AFTER THE NEW EC INSTALLATION; IT WAS THIS REQUEST THAT ALLOWED FSE TO SEE THE ERROR FIRSTHAND. FIRST, FSE TESTED THE ENDOSCOPE ON ANOTHER SYSTEM, AND IT CONNECTED WITHOUT ISSUE. ONCE THE ENDOSCOPE WAS CONNECTED BACK TO SYSTEM SK1224, ERROR 45312 APPEARED. FURTHER TROUBLESHOOTING THROUGH THE GBIT COM STATUS SHOWED THAT NODE 29 (VPFI) WAS NOT PRESENT; THIS IS THE DIRECT CONNECTION FROM THE DUAL CAMERA CCU (DOCO) TO THE UNIVERSAL (UNIT) CONTROLLER CARD (UCC) (SHORT GREY FIBER). FSE TRIED A DIFFERENT FIBER IN THE PLACE OF THE GREY FIBER WHILE THE VISION SIDE CART (VSC) WAS IN STANDALONE MODE AND ERROR 45312 APPEARED. THIS INDICATED THAT THE ISI CORE CONTROLLER (ICC) PRINTED CIRCUIT ASSEMBLY (PCA) WAS THE ISSUE. FSE ALSO REPLACE THE ICC PCA, VIDEO PROCESSOR (VP), AND A GREY FIBER CABLE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE EC, ICC, AND VP FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED. THE ROOT CAUSE OF ERROR 45312 POINTS TO LOSS OF RIGHT ENDOSCOPE VIDEO TO EC / RESEAT SCOPE CONNECTION (POSSIBLE SCOPE OR EC).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT ERRORS ON THE CAMERA AND CAMERA BOX. THE CUSTOMER WAS GETTING ERROR 45312 ON TWO DIFFERENT SCOPES. THE CUSTOMER WAS STILL GETTING THE 45312 ERRORS WITH BOTH SCOPES AFTER PROCEDURE COMPLETION. LOGS CONFIRMED THE 45312 ERROR. TSE RECOMMENDED CUSTOMER RESEAT THE CAMERA CABLE INTO THE CAMERA BOX 5-6 TIMES TO CLEAN THE PINS. CUSTOMER TRIED THIS WITH BOTH SCOPES AND WAS STILL GETTING THE ERROR 45312. CUSTOMER STATED THE RIGHT EYE HAD COLOR BARS, BUT THE LEFT EYE HAD AN IMAGE WITH BOTH SCOPES. CUSTOMER GOT A THIRD SCOPE AND THE ISSUE REMAINED. TSE RECOMMENDED TO CHECK THE ENDOSCOPE CONTROLLER (EC) CONNECTION FOR DAMAGE. CUSTOMER INSPECTED THE EC CONNECTOR AND PINS AND DIDN'T SEE ANY OBVIOUS DAMAGE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500291 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-26 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1