BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24693764 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18558
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    May 21, 2024
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED EVENT. FSE REPLACED THE COMMON COMPUTE CONTROLLER (CCC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. BASED ON THE INFORMATION PROVIDED, IT SEEMS THAT THE CUSTOMER'S CCC WAS CONNECTED TO AN ELECTRICAL TESTING FIXTURE. DURING THE TESTING, IT WAS DISCOVERED THAT THE UNIT'S FPGA (FIELD-PROGRAMMABLE GATE ARRAY) WAS IN A RECOVERY MODE STATE. THIS CONFIRMS THE CUSTOMER'S COMPLAINT. TO ADDRESS THE ISSUE, THE RECOMMENDED SOLUTION IS TO REPROGRAM THE UNIT TO ITS FACTORY PRODUCTION STATE. THIS WILL RESTORE THE CCC TO ITS ORIGINAL SETTINGS AND FUNCTIONALITY. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY WERE UNABLE TO USE THE DRIVE FUNCTION WHEN TRYING TO DRIVE THE ROBOT. CALLER STATED THAT THE POWER BUTTON IS FLASHING BLUE, BATTERY LEDS ARE GREEN BUT NO OTHER LEDS ILLUMINATED. CALLER STATED THAT THERE IS A MESSAGING SAYING CONNECT ROBOT TO THE TOWER TO START A PROCEDURE. PRIOR TO CONTACTING TECH SUPPORT ENGINEER (TSE), CALLER POWER CYCLED MULTIPLE TIMES BUT ISSUE REMAINED. TSE HAD CALLER HARD CYCLE AND EPO ROBOT BUT ISSUE REMAINED. TSE THEN HAD CALLER CONNECT THE TOWER TO THE ROBOT AND RECEIVED A 31030 ERROR INDICATING A START UP FAILURE. CALLER STATED THAT THE TOWER HAS POWERED ON BUT ROBOT HAS THE SAME ISSUE. TSE HAD CALLER HARD CYCLE AND EPO MULTIPLE TIMES TRYING TO POWER ON FROM TOWER AND ROBOT. ROBOT IS GETTING TO POWER SIGNAL BUT IS NOT BOOTING UP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269314 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-40 N/A 00886874119716

    Patients

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