BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 23850811 · Received December 19, 2025

    Report

    Report Number
    2955842-2025-48361
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE AND REASON FOR THE CONVERSION TO OPEN SURGERY CANNOT BE DETERMINED. THE CUSTOMER REPORTED THAT THERE WERE NO ISSUES WITH THE DA VINCI SYSTEM. THEREFORE, NO PRODUCTS ARE EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF THE SYSTEM LOGS INDICATES THE SYSTEM HAS BEEN USED IN SUBSEQUENT PROCEDURE. ADDITIONALLY, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY FURTHER REPORTED ISSUES AGAINST THE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AFTER APPROXIMATELY 9 HOURS OF SURGERY PERFORMED WITH DA VINCI, THE SURGEON AND HER TEAM DECIDED TO CONVERT INTO OPEN SURGERY TO FINISH THE PROCEDURE DUE TO TECHNICAL DIFFICULTY AND PROLONGED OPERATIVE TIMES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO TECHNICAL DIFFICULTY; AFTER APPROXIMATELY NINE HOURS HAD ELAPSED, THE SURGICAL TEAM DETERMINED THAT COMPLETING THE OPERATION WITH AN OPEN APPROACH WOULD BE FASTER AND EASIER. THIS DECISION WAS NOT PROMPTED BY ANY INTRA-OPERATIVE COMPLICATIONS, AS NONE WERE REPORTED DURING THE PROCEDURE. THERE WAS NO INDICATION THAT THE CONVERSION WAS DUE TO PATIENT ANATOMY¿SPECIFIC ANATOMICAL CHALLENGES SUCH AS EXTENSIVE ADHESIONS OR ABNORMAL TISSUE WERE NOT IDENTIFIED, AND THERE IS NO INFORMATION TO SUGGEST THE SURGEON ANTICIPATED A NEED TO CONVERT OR ABORT THE SURGERY BASED ON ANATOMICAL CONSIDERATIONS PRIOR TO STARTING. THE PATIENT TOLERATED THE CONVERSION WELL, WITH NO INJURIES REPORTED AS A RESULT OF THE CHANGE IN SURGICAL APPROACH. ADDITIONALLY, THERE WERE NO SYSTEM OR DEVICE MALFUNCTIONS NOTED EITHER BEFORE OR DURING THE DECISION TO CONVERT, AND ALL INSTRUMENTS AND DEVICES PERFORMED AS EXPECTED. THE SYSTEM WAS INSPECTED PRIOR TO USE, WITH NO ISSUES FOUND DURING SETUP, AND NO TROUBLESHOOTING WITH TECHNICAL SUPPORT WAS NECESSARY. THE PROCEDURE HAD BEEN ONGOING FOR APPROXIMATELY NINE HOURS WHEN THE DECISION TO CONVERT WAS MADE. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED FOLLOWING THE SURGICAL PROCEDURE, AND THUS, NO ADDITIONAL MEDICAL INTERVENTIONS WERE NECESSARY. THE CAUSE OF ANY POTENTIAL POST-OPERATIVE COMPLICATIONS REMAINS UNKNOWN, THOUGH NONE OCCURRED IN THIS CASE. FINALLY, A VIDEO RECORDING OF THE PROCEDURE IS NOT AVAILABLE FOR ISI REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238792 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-40 N/A 00886874115404

    Patients

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