BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 21267680 · Received January 29, 2025

    Report

    Report Number
    2955842-2025-00821
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 8, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INSUFFLATOR DUE TO INTERMITTENT FAULTS. THE FSE REPLACED THE TOWER'S CARD CAGE (CCC) TO BRING UP THE SYSTEM AFTER A POWER CYCLE BRICKING THE BOARD. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE INSUFFLATOR AND CCC BOARD FOR EVALUATIONS, BUT EVALUATIONS HAVE NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMMON COMPUTE CONTROLLER (CCC) WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED. THE REPORTED ISSUE IS NOT ASSOCIATED WITH AN ERROR CODE SO IT COULD NOT BE CONFIRMED THROUGH THE ERROR LOGS. THE CCC WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS TAKEN TO A PROGRAMMING STATION, WHERE IT WAS VERIFIED THAT IT WAS BRICKED PER IPC 1069151-01. AS A RESULT OF THE ABOVE FINDINGS, THE ROOT CAUSE WAS DETERMINED TO BE A BRICKED CCC. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE INSUFFLATOR WAS ALSO RETURNED AND THE REPORTED ISSUE WAS NOT REPLICATED NOR CONFIRMED. IN THE ERROR LOGS, NO RELEVANT EVENT OR ERROR LOGS WERE FOUND, WHICH DID NOT CONFIRM THE ISSUE. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM TO BE FUNCTIONALLY TESTED AND NO ISSUES WERE FOUND, NOT REPLICATING THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE INSUFFLATOR WAS FAULTING. THE OPERATING ROOM (OR) STAFF CYCLED SYSTEM POWER BEFORE CALLING. THE SYSTEM WOULD NOT SUCCESSFULLY POWER ON. THE SURGEON CONVERTED TO LAPAROSCOPIC SURGERY DURING THE CALL WITH THE CLINICAL SALES REPRESENTATIVE (CSR). THE LIVE SYSTEM LOGS WERE NOT AVAILABLE AT THE TIME. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE OR STAFF TO CYCLE SYSTEM POWER AND TOWER CIRCUIT BREAKER FOR OVER TWO MINUTES. THE SYSTEM FAILED TO COMPLETE POWER UP. THE TSE ASKED THE OR STAFF TO CYCLE SYSTEM POWER AND DISCONNECT BLUE FIBER CABLES. THE TSE ASKED THE OR STAFF TO CYCLE EACH COMPONENT ON IN STANDALONE MODE. THE OR STAFF CONFIRMED THE CONSOLE SUCCESSFULLY POWERED ON WITH SOLID BLUE POWER LED. THE OR STAFF CONFIRMED THE ROBOT SUCCESSFULLY POWERED ON WITH SOLID BLUE POWER LED. THE OR STAFF CONFIRMED THE TOWER FAILED TO SUCCESSFULLY POWER ON. THE TOWER POWER BUTTON LED WAS FLASHING BLUE AND NEVER COMPLETED POWER UP. THE OR STAFF REQUESTED FOR THE SYSTEM TO BE CHECKED AS SOON AS POSSIBLE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605771 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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