BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24946596 · Received April 21, 2026

    Report

    Report Number
    2955842-2026-22290
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 21, 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
    FL, 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 NOT CONFIRMED. FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED CO2 TANK INTERFACE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, TWO SETS OF TANKS LEAKED UNTIL THEY WERE COMPLETELY EMPTY WHEN CONNECTED TO THE VISION TOWER. DETAILS ABOUT THE EVENT WERE INITIALLY UNCLEAR, AND IT WAS INDICATED THAT ADDITIONAL INFORMATION MIGHT BE OBTAINED AND PROVIDED LATER. IT WAS ALSO STATED THAT THE STAFF MOVED TO ANOTHER SYSTEM AND WOULD NOT USE THE AFFECTED SYSTEM UNTIL THE ISSUE WAS RESOLVED BECAUSE HOUSE GAS WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111031 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

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