BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25118749 · Received May 7, 2026

    Report

    Report Number
    2955842-2026-24215
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. A REVIEW OF THE FIELD LOGS SHOWED THE ASSOCIATED ERROR CODES. NO PHYSICAL DAMAGE WAS FOUND. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND FAILED; THE SAME ERRORS OBSERVED IN THE FIELD WERE REPRODUCED. THE UNIT WAS THEN PLACED ON SYSTEM TO PERFORM FITNESS TESTING AND A 1 HOUR SINE CYCLE. THE UNIT FAILED WITH THE FOLLOWING: BACKDRIVE PLAT ERROR, ADV 30: SYSTEM ERR WHL HW INFO (AC 7A), NEL 307: SYSTEM ERR NODE NOT PRESENT (SCC), REL 23049: EEVT CB TRQ DISCONTINUITY (MCER), ENI 23918: EEVT SENSOR LATENCY ADVISORY (MCER), REL 25730: ERROR UCE ARMNET MAXM LATE (MCER), REL 25732: ERROR UCE ARMNET MAXM SEQ1 (MCER), NEL 25743: ERROR UCE HW REMOTE (MCER), REL 32097: SYSTEM ERR LOCAL FRL MAXIS FAULT (MCER), REL 32125: SYSTEM ERR LOCAL FRL COM WDOG FAULT (MCER), REL 32126: SYSTEM ERR LOCAL WHL HW FAULT (AC 7A), REL 32133: SYSTEM ERR LOCAL FRL SSYNC UNLOCK FAULT (AC 7A). MISSING NODE ERRORS WERE CONFIRMED AND REPLICATED. DUE TO THESE ERRORS, THE UNIT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED THE MASTER TOOL MANIPULATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A NON RECOVERABLE 17 FAULT. THE SITE THEN POWER CYCLED THE SYSTEM, AFTER WHICH 307 FAULTS OCCURRED. THE TECHNICAL SUPPORT ENGINEER REVIEWED THE SYSTEM LOGS AND IDENTIFIED AN ISSUE RELATED TO THE SECOND SURGEON CONSOLE. THE ENGINEER INSTRUCTED THE CUSTOMER TO DISCONNECT THE SECONDARY CONSOLE AND PERFORM ANOTHER POWER CYCLE, AFTER WHICH THE SYSTEM BOOTED AND OPERATED NORMALLY. THE PROCEDURE WAS BEING COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428521 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-50 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1