BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 23005610 · Received September 9, 2025

    Report

    Report Number
    2955842-2025-36561
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 18, 2025
    Report Date
    August 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON SITE AND REPLACED SIM 1 AND SIM 2 AS PART OF SOFTWARE UPGRADE. THE SITE WAS STILL NOT ALLOWING ALL TRAFFIC THROUGH THEIR FIREWALL. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE; THE CUSTOMER COULD NOT GET THE SURGEON SIDE CONSOLE (SSC) OUT OF SIM MODE. THE STAFF DID NOT HAVE TIME TO TROUBLESHOOT THE BLUE FIBER CABLES. THE PATIENT WAS UNDER ANESTHESIA, AND THE SURGEON DID NOT FEEL COMFORTABLE PROCEEDING. THE CUSTOMER STATED THAT THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SAID THE SIMULATOR ON THE SYSTEM NEEDED TO BE REPLACED. THE ISI TSE EXPLAINED TO CUSTOMERS THAT FOR THE CURRENT SOFTWARE, THE SSC NEEDED TO BE REBOOTED VIA THE POWER BUTTON TO EXIT SIM MODE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. ISI FOLLOWED UP WITH THE INITIAL REPORT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY PRIOR TO DOCKING, BUT AFTER PORT PLACEMENT. THE PATIENT TOLERATED THE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2869286 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

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