BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 24552332 · Received March 9, 2026

    Report

    Report Number
    2955842-2026-15525
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 4, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114735
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE SURGEON SIDE CONSOLE (SSC), VISION SIDE CART (VSC), AND PATIENT SIDE CART (PSC) WERE ALL RETURNED FOR FAILURE ANALYSIS FOR CUSTOMER SATISFACTION AFTER A SERIES OF PERSISTENT SYSTEM COMPLAINTS. AFTER REVIEWING SYSTEM LOGS, IT WAS FOUND THAT NO ERRORS WERE PRESENT THAT WOULD BE RELATED TO THE PRIOR COMPLAINTS. ALL DATA SHOWED THAT THE SYSTEMS WERE FUNCTIONING AS DESIGNED AT THE TIME OF SYSTEMS REPLACEMENTS. ALL CARTS RETURNED AS PART OF THIS COMPLAINT WERE ASSEMBLED AND TESTED TOGETHER. DURING VISUAL INSPECTION, NO ISSUES WERE IDENTIFIED THAT WOULD BE RELATED TO PRIOR COMPLAINTS. THE SYSTEMS WERE POWERED ON IN NORMAL MODE WITHOUT TRIGGERING ANY FAULTS OR ERRORS. THE SYSTEMS WERE DRIVEN AND POWER CYCLED 30 TIMES WITHOUT TRIGGERING ANY FAULTS OR ERRORS. ALL JOINTS WERE ACTUATED, ALL BUTTONS AND SWITCHES WERE EXERCISED, AND THE SYSTEMS FUNCTIONED AS DESIGNED. TESTING WAS ALSO PERFORMED ON BOTH SSC¿S MASTER TOOL MANIPULATORS (MTM), AND THE PSC¿S COLUMN, SHOULDER, BOOM, AND ENTRY GUIDE MANIPULATOR (EGM) AXIS, AND WAS ABLE TO PASS ALL TESTING. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE SURGEON SIDE CONSOLE (SSC), VISION SIDE CART (VSC), AND PATIENT SIDE CART (PSC) DUE TO MULTIPLE REPORTED ISSUES ON THE SYSTEMS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE SSC, VSC, PSC OR FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WERE MULTIPLE REPORTED ISSUES ON THE SURGEON SIDE CONSOLE (SSC), VISION SIDE CART (VSC), AND PATIENT SIDE CART (PSC). NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. FOLLOW-UP WITH FIELD SERVICE ENGINEER (FSE) VIA PHONE AND PROVIDED ADDITIONAL INFORMATION REGARDING THE COMPLAINT: THE FSE REPORTED THIS SITE HAS HAD MULTIPLE SYSTEM EVENTS CAPTURED UNDER INDIVIDUAL WORK ORDERS. THE FSE STATED THERE WAS NO PROCEDURE CONVERSION FROM SINGLE PORT TO MULTI PORT ON THE REPORTED EVENT DATE OF 02/09/2026. THE FSE WAS REFERRING TO A PAST EVENT ON 01/21/2026 CAPTURED UNDER PR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216280 DA VINCI SP SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380940-33 N/A 00886874114735

    Patients

    Seq Age Sex Outcome Treatment
    1