BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24708395 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18881
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    October 23, 2025
    Report Date
    March 26, 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
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. CUSTOMER REPORTED ERROR 297 AT START UP. FSE REPROGRAMMED SYSTEM'S COMMON COMPUTE CONTROLLER (CCC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS DUE TO THE SOFTWARE CONVERTING TO A NON-CLINICAL (GOLDEN IMAGE). THIS ISSUE CAN BE RESOLVED BY HAVING THE FSE REPROGRAM THE SYSTEM. THIS ISSUE IS ALSO CAPTURED IN THE CLINICAL RISK ANALYSIS, GEN5, SYSTEM (818555-10, REV V) VIA RISK ID G5-SYS-5637.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED ERROR 297 AT STARTUP. THE SYSTEM IS NOT POSTING TO ONSITE. POPUP LOGS SHOW 297 AND 307 WITH SOME 311'S. THE 311 ERROR IS A GOLDEN IMAGE ERRORS. THE REPORTING NODE FOR 311 IS SURGEON SIDE CONSOLE(SSC) NODE 33. MOST LIKELY REPROGRAMING WILL RESOLVE THE ISSUE BUT BRING A COMMON COMPUTER CONTROLLER (CCC) AND SIOX CARD CAGE FOR SIM. THIS IS A DOWN SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18708 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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