BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 24364328 · Received February 17, 2026

    Report

    Report Number
    2955842-2026-03999
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 17, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 REPLACED PATIENT SIDE MANIPULATOR (PSM) 3 TO RESOLVE THE ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SUPPORT ENGINEER (TSE) WHILE USING A SINGLE PORT (SP) SYSTEM, THAT THERE WAS A REPORTED ERROR ON PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER REBOOTED THE SYSTEM TO RESOLVE THE ISSUE; HOWEVER, THE SURGEON PREFERRED TO CONVERT THE PROCEDURE WITH A DA VINCI MULTIPORT SYSTEM TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE REPORTER CONFIRMED THAT THE PROBLEM OCCURRED DURING THE FIRST AND ONLY PROCEDURE PERFORMED WITH THE SP0459 SYSTEM. THE PROCEDURE WAS CONVERTED FROM SINGLE PORT TO A MULTI-PORT XI SYSTEM DUE TO THE SYSTEM ISSUE DURING THE PARTIAL NEPHRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427830 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

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