BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23688179 · Received December 1, 2025

    Report

    Report Number
    2955842-2025-47031
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 31, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED PN: 658350-26 PCE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN LIGHTHOUSE, ERROR 319 WAS FOUND INDICATING COMMUNICATION FAULT FAILURE - NODE NOT PRESENT AND CONFIRMING THAT THIS FAULT DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PCE BOARD WAS INSTALLED, PROGRAMMED AND TESTED ON THE DV5 IN HOUSE SYSTEM AT LOCATION PCE 5 SLOT OF THE PSC CARDCAGE WHERE IT TRIGGERED ERROR 319 (COMMUNICATION FAULT - NODE NOT PRESENT). THIS UNIT WAS BROUGHT TO BENCH TEST STATION AND VERIFIED THAT THE BOARD DIDN'T FULLY POWER UP. USING DIGITAL MULTIMETER AND CHECK ON 6 TEST POINT (TP) AND THERE WERE NO VOLTAGE READINGS. NO SHORT, NO SOLDER DEFECTS AND NO DAMAGES WERE OBSERVED ON THE BOARD COMPONENTS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE IS ATTRIBUTED TO AN ELECTRICAL FAILURE OF THE PCE BOARD. THIS ISSUE MAY BE RESOLVED BY FSE REPLACEMENT OF THE PCE BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REPRESENTATIVE CONTACTED TECHNICAL SUPPORT REMOTELY, INDICATING THAT THE CUSTOMER'S PATIENT SIDE CART (PSC) WAS DISPLAYING A FAULT MESSAGE STATING THE BOOM WAS DISABLED, AND IT COULD NOT BE MOVED. AS A RESULT, THE PSC HAD TO BE SWAPPED WITH ANOTHER UNIT. THE TECHNICAL SUPPORT ENGINEER REVIEWED THE LOGS AND IDENTIFIED ERROR CODE 319 ON ARMNET 1, WITH PREVIOUS LOGS SHOWING ERROR CODE 31089 ON FIBER PORT 3. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A INGUINAL HERNIA. PROCEDURE WAS COMPLETED ROBOTICALLY WITH ANOTHER PATIENT CART. THE PROCEDURE WAS DELAYED BY 30 MINUTES.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756044 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

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