BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694658 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17938
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 25, 2024
    Report Date
    March 25, 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
    WA, 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. THE FSE REPLACED THE COMMON COMPUTE CONTROLLER (CCC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THIS UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED "INSUFFLATOR HAS BEEN DISABLED." WAS CONFIRMED AND REPLICATED. THIS ISSUE IS A SYMPTOM OF A BRICKED UNIT. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. PERFORMED BENCH TESTING ON THIS UNIT AND CONFIRMED THAT UNIT IS BRICKED. UNIT WAS INSTALLED ON THE KNOWN GOOD IN-HOUSE AND TOWER MONITOR DID NOT SHOW FULL DISPLAY AND POWER BUTTON KEPT FLASHING BLUE WHICH ATTRIBUTES TO THE COMPLAINT. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE TEGRA MODULE IS THE ROOT CAUSE OF THE ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN "INSUFFLATOR DISABLED" MESSAGE ON THE SCREEN. THE OPERATING ROOM (OR) STAFF CYCLED THE SYSTEM POWER TWO TIMES BEFORE CALLING. THE PATIENT WAS NOT IN THE ROOM. THE OR STAFF CONFIRMED THE TOWER POWER BUTTON WAS FLASHING BLUE. THE TOWER NEVER POWERED ON COMPLETELY. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE OR STAFF TO CYCLE TOWER POWER. THE TSE ASKED THE OR STAFF TO CYCLE TOWER CIRCUIT BREAKER FOR OVER ONE MINUTE. THE TSE ASKED THE OR STAFF TO DISCONNECT BLUE FIBER CABLES FROM THE TOWER. THE "INSUFFLATOR DISABLED" MESSAGE RETURNED WITH FLASHING BLUE LED ON TOWER POWER BUTTON. THE TSE ASKED THE OR STAFF TO POWER THE ROBOT AND CONSOLE IN STANDALONE MODE. THE STAFF CONFIRMED THE ROBOT AND CONSOLE BOTH COMPLETED POWER UP WITH SOLID BLUE LED ON POWER BUTTONS. THE OR STAFF PLANNED TO ABORT TO ANOTHER DA VINCI. THE PROCEDURE WAS ABORTED TO ANOTHER DA VINCI PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331583 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

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