BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24784191 · Received April 3, 2026

    Report

    Report Number
    2955842-2026-20644
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 28, 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
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. FIELD SERVICES ENGINEER WAS DISPATCHED ON SITE AND CONFIRMED ERROR 66200. THE ADVANCED PROCESSOR WAS REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE ADVANCE PROCESSOR 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 PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, REPEATED OCCURRENCES OF RECOVERABLE FAULT 66200 WERE OBSERVED. THE CUSTOMER STATED THAT THE SYSTEM WAS POWER CYCLED, BUT THIS WAS AN ON-GOING ISSUE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100991 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1