BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23588210 · Received November 18, 2025

    Report

    Report Number
    2955842-2025-45574
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 18, 2025
    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
    GM
    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 319. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE EC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED RECTOPEXY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED A REPEATED NON-RECOVERABLE FAULT 319. THE TSE REVIEWED THE ERROR LOGS AND IDENTIFIED THE ISSUE ORIGINATING FROM THE ENDOSCOPE CONTROLLER (EC). THE TSE INSTRUCTED THE USER TO CHECK THE LED NEXT TO THE ENDOSCOPE INPUT, WHICH WAS NOT LIT, AND GUIDED THEM THROUGH SHUTTING DOWN THE SYSTEM AND VERIFYING THE EC POWER SWITCH WAS ON. THE USER WAS ALSO ADVISED TO RECONNECT THE ORANGE FIBER CABLE FROM THE EC TO THE VIDEO PROCESSOR AND THE POWER CORD TO THE EC, BUT THESE STEPS DID NOT RESOLVE THE ISSUE. CONSEQUENTLY, THE SURGERY WAS LIKELY TO BE CONVERTED TO LAPAROSCOPIC AS THE USER DID NOT HAVE A SECOND DA VINCI SYSTEM AVAILABLE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITH NO HARM TO THE PATIENT AND NO DELAY, AS ERROR COULD NOT BE RECOVERED. NO ADDITIONAL PORTS HAVE BEEN PLACED; THE EXISTING PORTS HAD TO BE CHANGED FROM 8MM TO 12MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863328 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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