BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 24495538 · Received March 3, 2026

    Report

    Report Number
    2955842-2026-14646
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 3, 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
    KS
    Reporter Occupation
    NURSE
    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 EVENT. THE FSE WENT ON SITE AND FOUND ERROR "NODE NOT PRESENT." THE FSE SWAPPED PATIENT SIDE MANIPULATOR 1, AND 2 (PSM) BUT ERROR PERSISTED ON SAME ARMNET 1. THE FSE REPLACED THE HALO AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, ERRORS OCCURRED REPEATEDLY DURING PATIENT SIDE CART (PSC) DOCKING. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD CUSTOMERS PERFORM A HARD POWER-CYCLE, BUT THE ISSUE PERSISTED. THE TSE FOUND ERRORS ON THE PATIENT SIDE MANIPULATOR 1 (PSM) AND ON STAR IN THE LOGS. THE PROCEDURE WAS CONVERTED FROM A SINGLE PORT PROCEDURE TO LAPAROSCOPY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGICAL PROCEDURE WAS CONVERTED FROM A ROBOTIC TO A TRADITIONAL LAPAROSCOPIC APPROACH DUE TO AN UNRECOVERABLE SYSTEM ERROR WITH THE PATIENT SIDE CART (PSC), WHICH COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING EFFORTS. THE SURGICAL TEAM PROCEEDED USING THE SAME PORT CONFIGURATION; THUS, THE CONVERSION DID NOT NECESSITATE INCREASED PORT SIZE OR THE ADDITION OF EXTRA PORTS. THERE WAS NO INFORMATION WHETHER THE PATIENT TOLERATED THE CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559035 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

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