BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24538045 · Received March 6, 2026

    Report

    Report Number
    2955842-2026-15236
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE FAILURE WAS NOT REPLICATED DURING FIELD SERVICE AND FAILURE ANALYSIS TESTING, THE ERROR OBSERVED IN THE SYSTEM LOGS INDICATE A POSSIBLE COMMUNICATION ISSUE WITHIN THE SYSTEM. ERRORS OCCUR WHEN THE SYSTEM HAS DETECTED A POTENTIAL ISSUE, OR WHEN IT CANNOT BE SURE THERE IS NO ISSUE AND, THEREFORE, THE SYSTEM TRANSITIONS TO A SAFE ERROR STATE. THIS ISSUE CAN BE RESOLVED BY POWER CYCLING THE SYSTEM OR CONTACTING ISI FOR SYSTEM SERVICE.

    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 NOT CONFIRMED. FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE COMMON COMPUTE CONTROLLER TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THIS UNIT WAS RETURNED FOR FAILURE ANALYSIS DUE TO ERROR 31089. THE ERROR WAS CONFIRMED BUT COULD NOT BE REPLICATED. VISUAL INSPECTION SHOWED THE UNIT WAS IN GOOD PHYSICAL CONDITION. THE ERROR LOG IN LIGHTHOUSE CONFIRMED THE ISSUE OCCURRED IN THE FIELD. THE UNIT WAS INSTALLED INTO A GOLDEN SYSTEM AND LEFT IDLE FOR 4 HOURS, WITH PERIODIC POWER CYCLING PERFORMED 10 TIMES. EACH TIME, THE SYSTEM STARTED UP WITHOUT ERROR. OPTIC LIGHT LEVELS WERE CHECKED, AND ALL VALUES WERE WITHIN THE EXPECTED RANGE. BASED ON THESE FINDINGS, FAILURE ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE OF THE 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 CASE SETUP, THE SYSTEM POWERED ON WITH A CONNECTION ERROR AND A PROMPT TO RESTART. SYSTEM EVENT LOGS INDICATED A 31089 ERROR FROM TOWER FIBER PORT 1 AND THE CONSOLE. THE CUSTOMER REBOOTED THE SYSTEM AND SWAPPED THE TOWER FIBER CONNECTION TO THE CONSOLE TO TOWER FIBER PORT 3, BUT THE ISSUE PERSISTED. THE CUSTOMER DECIDED NOT TO TROUBLESHOOT FURTHER AND MOVED THE CASE TO ANOTHER ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607241 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

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