BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI 5

    MDR report key: 23984626 · Received January 6, 2026

    Report

    Report Number
    2955842-2026-00406
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 30, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSUFFLATOR WAS ANALYZED. FAILURE ANALYSIS COULD NOT CONFIRM NOR REPLICATE THE REPORTED COMPLAINT. UPON VISUAL INSPECTION, NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND. THE INSUFFLATOR WAS INSTALLED ONTO AN IN-HOUSE SYSTEM, AND THE SYSTEM DID NOT TRIGGER ANY ISSUES OR ERRORS AT STARTUP. THE INSUFFLATOR WAS RESPONSIVE. THE INSUFFLATOR WAS THEN INSTALLED ON A GOLDEN VALID TUBE SET, AND THE INSUFFLATOR WAS ABLE TO ENGAGE. WHEN THE INSUFFLATOR WAS INSTALLED ON AN INVALID TUBE SET, ERROR MESSAGE ¿INVALID TUBE SET¿ WAS TRIGGERED, AND THE LIGHT RING ON THE INSUFFLATOR KEPT FLASHING YELLOW. INSUFFLATOR FUNCTIONAL TEST WAS PERFORMED, AND THE INSUFFLATOR PASSED ALL TESTS WITH NO AIR LEAKAGE.

    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. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT, BUT FAILURE ANALYSIS IS IN PROGRESS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT THE INSUFFLATOR OF THE DV 5 SYSTEM BECAME INOPERABLE AND USED TWO TANKS OF GAS. THE CUSTOMER USED A THIRD-PARTY INSUFFLATOR TO RESOLVE THE ISSUE. THE CSR VERIFIED THAT THERE WAS NO GAS LEAK IN THE SYSTEM. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36139 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 Female DA VINCI INSTRUMENTS AND ACCESSORIES.