BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23908255 · Received December 29, 2025

    Report

    Report Number
    2955842-2025-49394
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 2, 2025
    Report Date
    January 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REPLACED ADVANCED PROCESSOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ADVANCED PROCESSOR (AP) 5000 WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD SYSTEM AND POWERED ON WITH NO ISSUES. THE AP 5000 WAS INSPECTED, WHERE THE LEDS WERE ON AND THE FANS WERE SPINNING. THE SYSTEM WAS LEFT TO IDLE FOR TWO HOURS, AND POWER CYCLED FIVE TIMES WITH NO ISSUES. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED EVENT WAS NOT CONFIRMED AS FAILURE ANALYSIS OF THE PRODUCT FOUND NO FUNCTIONAL ISSUE. THE PRODUCT WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PRODUCT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OR STAFF CALLED TECH SUPPORT AFTER A PROCEDURE, INDICATING THEY RECEIVED A MESSAGE ABOUT AN ADVANCED PROCESSOR ERROR DURING THE SETUP. THE CALLER ASSISTED THE STAFF OVER THE PHONE, INSTRUCTING THEM TO MANUALLY MOVE THE ROBOT AWAY FROM ANY WALLS AND PERFORM A REBOOT, WHICH INITIALLY CLEARED THE ERROR. HOWEVER, 20 MINUTES LATER, AS THEY WERE ABOUT TO DOCK, THE SURGEON ABORTED THE PROCEDURE DUE TO PATIENT ANATOMY, AND WHILE BACKING THE ROBOT OUT, THE ADVANCED PROCESSOR ERROR REAPPEARED. THE TECHNICAL SUPPORT ENGINEER REVIEWED THE LOGS AND IDENTIFIED ERROR CODE 66200, WHICH POINTED TO AN MVP ISSUE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: COORDINATOR CONFIRMED THAT A PORT WAS PLACED. AFTER REVIEWING THE ANATOMY, THE PHYSICIAN DETERMINED THAT IT WAS NOT GOOD TO DO ROBOTICALLY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600523 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

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