BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 22916095 · Received August 28, 2025

    Report

    Report Number
    2955842-2025-35844
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 4, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WILL BE RETURNED AS THE SYSTEM FUNCTIONED AS INTENDED. A FIELD SERVICE ENGINEER INSPECTED THE SYSTEM AND CONFIRMED THAT THERE WERE NO ISSUES WITH IT. INSTEAD, THE CRC TECHNOLOGIES WERE IDENTIFIED AS DIFFICULT TO USE, PARTICULARLY DURING INSTRUMENT EXCHANGES, RESULTING IN LONGER PROCESSING TIMES FOR SUBSEQUENT CASES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, USER REPORTED THAT THERE WERE CHALLENGES WITH THE USE OF THE CUSTOM REMOTE CENTER (CRC) FEATURE, WHICH CREATED UNNECESSARY STRESS FOR THE STAFF AND POSED INTRAOPERATIVE CHALLENGES WHILE OPERATING NEAR THE PARENCHYMAL WALL. PARENCHYMA WALL. THERE WAS NO INJURY OR BLEEDING DUE TO THIS AT ALL. THE USER NOTED THAT THERE WERE NO ISSUES WITH THE SYSTEM ITSELF, BUT THE DIFFICULTIES WITH THE CRC LED TO IT BEING DISABLED. HOWEVER, BY THAT POINT, THE SURGEON HAD ALREADY DECIDED TO CONVERT THE CASE TO OPEN. THE USER EXPRESSED A DESIRE FOR THE CRC FEATURE TO BE MORE USER-FRIENDLY TO PREVENT SUCH COMPLICATIONS IN THE FUTURE. THE REPORTER CONFIRMED THAT THE PROCEDURE WAS CONVERTED TO OPEN DUE TO FRUSTRATION WITH THE CUSTOM REMOTE CENTER (CRC) ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240223 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-34 N/A 00886874114605

    Patients

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