BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24949115 · Received April 22, 2026

    Report

    Report Number
    2955842-2026-22463
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 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
    FL, 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. THE FSE REPLACED THE VISION SIDE CART POWER DISTRIBUTION BOARD (VSPD) TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT A RECURRING TOWER OVERHEATING MESSAGE. THE TSE HAD THE CALLER VERIFY THAT THERE WERE NO OBSTRUCTIONS IN FRONT OF THE TOWER, WHICH THE CALLER CONFIRMED, AND ALSO CONFIRMED THERE WAS NO VISIBLE DUST IN THE FRONT OF THE TOWER. THE TSE THEN RECOMMENDED THAT THE CUSTOMER POWER DOWN THE SYSTEM BETWEEN CASES TO ALLOW THE SYSTEM TO COOL OFF, AND THE CALLER AGREED TO INFORM THE STAFF BEFORE THE CALL ENDED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272900 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1