BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 24227371 · Received January 30, 2026

    Report

    Report Number
    2955842-2026-02659
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 7, 2026
    Report Date
    January 30, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 REPORTED COMPLAINT AND REPLACED THE PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PSM INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE USER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY EXPERIENCED REPEATED INSTRUMENT RECOGNITION FAILURES ON PATIENT SIDE MANIPULATOR (PSM) 2 WHEN ATTEMPTING TO INSTALL A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE USER ATTEMPTED TO RESEAT BOTH THE STERILE ADAPTOR AND THE INSTRUMENT, BUT THE ISSUE PERSISTED. DESPITE THIS, THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE SURGEON DISCONTINUED USE OF ARM 2 DUE TO AN ISSUE NEAR THE END OF THE PROCEDURE. DESPITE THIS, THE CUSTOMER WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE ROBOTICALLY USING THE REMAINING THREE ARMS. THERE WERE NO REPORTED ISSUES WITH ARM 2 IN SUBSEQUENT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289787 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

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