BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 22721211 · Received August 5, 2025

    Report

    Report Number
    2955842-2025-33022
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 16, 2025
    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
    AZ, US
    Reporter Occupation
    003

    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 ISSUE. FSE REPLACED PN: 656810-21 COMMON COMPUTE CONTROLLER (CCC) 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.

    Additional Manufacturer Narrative · 0

    ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE CCC WAS VISUALLY INSPECTED AND NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ON A KNOWN WORKING IN-HOUSE SYSTEM AND THE TOWER¿S MONITOR DID NOT SHOW FULL DISPLAY ON THE SCREEN. THE POWER BUTTON KEPT FLASHING BLUE AND WAS NOT ABLE TO POWER ON COMPLETELY. THE UNIT WAS PUT ON A PROGRAMMING STATION WHERE IT WAS CONFIRMED TO BE NON-FUNCTIONAL. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE IS ATTRIBUTED TO A NON-FUNCTIONAL CCC. THIS ISSUE CAN BE RESOLVED BY FSE REPLACEMENT OF THE PART.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM WAS NOT CONNECTED. A CALL WAS MADE OUTSIDE OF A CASE TO REPORT ISSUES WITH THE SYSTEM, INCLUDING A MESSAGE INDICATING THAT THE INSUFFLATOR WAS DISABLED AND THE CONSOLE WAS NOT CONNECTED TO THE SYSTEM. DESPITE PERFORMING A HARD POWER CYCLE AND RESEATING THE FIBER CABLES, THE ISSUES PERSISTED. THE TECHNICAL SUPPORT ENGINEER ATTEMPTED TO REVIEW THE LOGS, BUT THEY HAD STOPPED RESPONDING EARLY IN THE MORNING. IT WAS INQUIRED WHETHER THERE HAD BEEN A POWER OUTAGE OR GENERATOR CYCLING AT THAT TIME, BUT THIS WAS UNKNOWN. THE CALLER WAS GUIDED THROUGH ANOTHER HARD POWER CYCLE AND INSTRUCTED TO POWER ON EACH CART INDIVIDUALLY. HOWEVER, THE TOWER AND CONSOLE STILL EXHIBITED BLINKING POWER BUTTONS AND THE SAME SYMPTOMS REMAINED. A FIELD ENGINEER WAS REQUESTED TO INSPECT THE SYSTEM FURTHER. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288094 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