BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 23413596 · Received October 29, 2025

    Report

    Report Number
    2955842-2025-42951
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A SITE VISIT AND REPLACED THE INSUFFLATOR TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INSUFFLATOR ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS DID NOT CONFIRM THE REPORTED EVENT. THE UNIT WAS VISUALLY INSPECTED, AND NO ISSUES WERE FOUND TO BE RELATED TO THE EVENT. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD IN-HOUSE SYSTEM, AND IT PASSED SELF-TESTING. THE UNIT WAS ABLE TO DETECT VALID AND INVALID TUBE SET WHEN ENGAGED. THERE WAS NO GAS LEAKAGE OBSERVED. FUNCTIONAL TESTING ON THE UNIT WAS PERFORMED, AND IT PASSED THE OCCLUSION DETECTION TEST. THE UNIT PASSED THE INSUFFLATION AND DESUFFLATION TESTS FOR BOTH STANDARD AND THORACIC MODES. THE FLOWRATE STAYED CONSISTENT THROUGHOUT ALL TESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE PATIENT HAD DIFFICULTY TOLERATING INSUFFLATION. THERE WAS A CONCERN THAT THE FLOW RATE OF THE DA VINCI INSUFFLATOR WAS CONTRIBUTING TO A RISE IN THE PATIENT'S END-EXPIRATORY CARBON DIOXIDE AND POTENTIAL INSTABILITY. THE DA VINCI INSUFFLATOR WAS DISCONTINUED, AND A THIRD-PARTY AIRSEAL INSUFFLATOR WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT TOLERATED INSUFFLATION AFTER THE DA VINCI INSUFFLATOR WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214072 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

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