BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI 5

    MDR report key: 24694389 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18529
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    June 13, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE COMMON COMPUTE CONTROLLER (CCC) AND INSUFFLATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. FA INVESTIGATION DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. UNIT WAS INSTALLED ONTO THE KNOWN GOOD IN-HOUSE SYSTEM AND SYSTEM DID NOT TRIGGER ANY ISSUES OR ERRORS AT STARTUP. UNIT WAS RESPONSIVE. INSTALLED A GOLDEN VALID TUBE SET AND THE INSUFFLATOR WAS ABLE TO ENGAGE. INSTALLED AN INVALID TUBE SET AND UNIT TRIGGERED ERROR MESSAGE ¿INVALID TUBE SET¿ AS WELL AS LIGHT RING ON THE INSUFFLATOR KEPT FLASHING YELLOW. PERFORMED INSUFFLATOR FUNCTIONAL TEST AND UNIT PASSED ALL TESTS. NOTHING SEEMED TO BE WRONG WITH IT AND NO AIR LEAKAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSUFFLATOR WAS NOT DETECTED, PROMPTING THE CUSTOMER AND REPRESENTATIVE TO CONTACT TECHNICAL SUPPORT. THE SITE ATTEMPTED POWER CYCLING, HARD CYCLING, AND CHECKED CONNECTIONS, BUT THE INSUFFLATOR REMAINED UNDETECTED. TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO ENSURE THAT HOUSE GAS WAS SELECTED AND ADVISED ADJUSTING THE HOUSE GAS TO 56 PSI. HOWEVER, THE CUSTOMER STATED THEY NEEDED ASSISTANCE TO ADJUST THE HOUSE GAS AS THEY WERE UNSURE HOW TO DO IT. CONSEQUENTLY, THE SITE DECIDED TO PROCEED WITH THIRD-PARTY INSUFFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61990 DA VINCI 5 INSUFFLATOR AND TUBE SET WITH SMOKE EVACUATION NAY INTUITIVE SURGICAL, INC 373750-20 N/A

    Patients

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