BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 24993148 · Received April 26, 2026

    Report

    Report Number
    2955842-2026-22952
    Event Type
    Malfunction
    Date Received
    April 26, 2026
    Date of Event
    March 29, 2026
    Report Date
    April 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE PSM HAS NOT YET BEEN RECEIVED BY ISI FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE CUSTOMER EXPERIENCED ERROR 25823. THE CAMERA ARM WAS THE ONE FAULTING AND THE OTHER ARMS SEEMED TO BE GOOD. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) ATTEMPTED TO RECOVER AND EVEN PERFORMED A HARD POWER CYCLE, BUT THE FAULT KEEPS RETURNING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE TRAINING SESSION WAS COMPLETED. THE REPORTER BELIEVED A FIELD ENGINEER CAME OUT AND RESOLVED THE SITUATION FOR THAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497672 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-48 N/A 00886874114605

    Patients

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