BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694191 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18402
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    October 22, 2025
    Report Date
    March 25, 2026
    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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. FSE REPLACED THE PCE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PCE WAS ANALYZED AND IN THE LOGS, ERROR 319 WAS FOUND INDICATING COMMUNICATION FAULT FAILURE OF NODE NOT PRESENT AND CONFIRMED THAT THIS FAULT DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS PCE WAS INSTALLED, PROGRAMMED AND TESTED ON THE DV5 IN HOUSE GOLDEN SYSTEM AT LOCATION PCE 2 SLOT OF THE PATIENT SIDE CART (PSC) CARDCAGE WHERE IT TRIGGERED ERROR 319 (COMMUNICATION FAULT OF NODE NOT PRESENT) ON USM COMPUTE ENGINE (UCE) 2. THIS UNIT WAS BROUGHT TO BENCH TEST STATION AND VERIFIED THAT THE BOARD DIDN'T FULLY POWER UP. FURTHER TROUBLESHOOTING WAS PERFORMED BY USING LT POWERPLAY TOOL TO CHECK ON THE PCE'S, RESULTED THERE WAS NO POWER COMING THROUGH THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD AND WAS NOT TALKING TO THE BOARD. THE UNIT WAS CHECKED ON 6 TEST POINT (TP) AND THERE WERE NO VOLTAGE READINGS. NO SHORT, NO SOLDER DEFECTS AND NO DAMAGES WERE OBSERVED ON THE PCA BOARD COMPONENTS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A NON-RECOVERABLE ERROR ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. SYSTEM LOGS CONFIRMED 319 ERRORS ORIGINATING FROM THE USM COMPUTE ENGINE (UCE)/PATIENT SIDE CART (PSC) COMPUTE ENGINE (PCE) 2. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO PERFORM SEVERAL HARD RESTARTS, BUT THIS DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS CONSIDERING OTHER OPTIONS FOR CONTINUING THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27123 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

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