BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24949109 · Received April 22, 2026

    Report

    Report Number
    2955842-2026-22448
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 14, 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
    OH, 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 INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INSUFFLATOR TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INSUFFLATION DISPLAYED AN ORANGE LIGHT AND THE TUBESET WAS NOT WORKING. IT WAS NOTED THAT THE SYSTEM HAD ALREADY BEEN POWER CYCLED AND INDICATED THAT IT WAS READY, BUT INSUFFLATION STILL DID NOT FUNCTION. THE OPERATING ROOM STAFF REPORTED THEY WERE USING HOUSE GAS, THOUGH THEY COULD NOT CONFIRM THAT THE CORRECT GAS SOURCE WAS SELECTED ON THE SYSTEM. THE TEAM THEN CHOSE TO CONTINUE THE PROCEDURE USING A THIRD-PARTY INSUFFLATOR AND PLANNED TO CALL BACK AFTER THE CASE TO PERFORM A HARD RESET OF THE TOWER. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327751 DAVINCI 5 INSUFFLATOR AND TUBE SET WITH SMOKE EVACUATION NAY INTUITIVE SURGICAL, INC 373750-20 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1