BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI X

    MDR report key: 24376869 · Received February 18, 2026

    Report

    Report Number
    2955842-2026-04750
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, G3, G6, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY FOR FAILURE ANALYSIS EVALUATION. A VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE CUSTOMER REPORTED ISSUE. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM. THE SYSTEM WAS POWER CYCLED 10 TIMES AND SET TO IDLE FOR ONE HOUR. THE ERROR CONFIRMED IN THE LOGS DID NOT RETURN.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A SITE VISIT, VERIFIED THE ERROR, AND REPLACED THE CORE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ERROR. ISI HAS NOT RECEIVED THE COMPONENT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS WAS PERFORMED, AND REVEALED THE FOLLOWING POSSIBLE RELATED ERRORS: - POWER DISTRIBUTION BOARD ANALOG TO DIGITAL CONVERTER (ADC) FAULT - THE MASTERY SUPERVISORY CONTROLLER (MSC) SAW AN ACD VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V - POWER DISTRIBUTION BOARD ADC FAULT - THE MSC SAW AN ACD VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, A PERSISTENT NON-RECOVERABLE SYSTEM ERROR OCCURRED PRIOR TO DOCKING THE PATIENT SIDE CART (PSC), RESULTING IN ABORTION OF THE SURGERY. THE ISSUE OCCURRED AFTER PORT PLACEMENT, WHILE PREPARING TO DOCK THE PSC, WHEN THE SYSTEM DISPLAYED A NON-RECOVERABLE ERROR. AFTER INITIAL TROUBLESHOOTING OF THE FIBERS BY THE CUSTOMER, INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED. THE TSE REVIEWED THE SYSTEM LOGS AND CONFIRMED THE RECURRENCE OF THE ERROR, WHICH WAS ATTRIBUTED TO AN INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD) ERROR. THE TSE DIRECTED THE CUSTOMER TO PERFORM A HARD POWER CYCLE; HOWEVER, THE ERROR REAPPEARED IMMEDIATELY UPON RESTART. WHEN ASKED ABOUT THE AVAILABILITY OF A BACKUP SYSTEM, THE CUSTOMER INDICATED THAT THEIR OTHER SYSTEM WAS ALREADY IN USE. DUE TO THE PERSISTENT ISSUE AND INABILITY TO DOCK THE PSC, THE SURGEON DECIDED TO ABORT THE PROCEDURE AND RESCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321786 DA VINCI X VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-09 N/A 00886874115343

    Patients

    Seq Age Sex Outcome Treatment
    1