BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24868198 · Received April 14, 2026

    Report

    Report Number
    2955842-2026-21346
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 7, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SIDE CART (PSC) CARD CAGE WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERRORS 31089, 170, AND 307 WERE CONFIRMED IN THE REVIEW LOGS BUT COULD NOT BE REPLICATED DURING TESTING. ACCORDING TO THE LOGS REVIEW, THESE ERRORS WERE FOUND, CONFIRMING THAT THE FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION REVEALED NO ISSUES RELATED TO THE REPORTED EVENT. THE PSC CARD CAGE WAS THEN INSTALLED IN A GOLDEN SYSTEM, WHERE THE COMPONENT FUNCTIONED AS EXPECTED. FIBER OPTIC LIGHT LEVELS ON THE COMMON COMPUTE CONTROLLER (CCC) WERE INSPECTED VIA LOCALHOST:8050, AND ALL MEASUREMENTS WERE WITHIN THE EXPECTED RANGE. THE SYSTEM UNDERWENT TEN POWER CYCLES, FOLLOWED BY A 12-HOUR IDLE PERIOD IN THE GOLDEN SYSTEM, WITH NO ISSUES OBSERVED DURING TESTING. BASED ON THESE RESULTS, FAILURE ANALYSIS WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR THE REPORTED EVENTS ON THIS PSC CCC.

    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 THE CARD CAGE 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.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM POWERED ON WITH A BOOM ERROR, AND WHEN RECOVERY WAS ATTEMPTED, THE FAULT TRANSITIONED TO A 319 ERROR ON ARM 4. THE SITE PERFORMED MULTIPLE EMERGENCY POWER OFFS OF THE PATIENT SIDE CART, BUT THESE DID NOT CHANGE THE ERROR BEHAVIOR. IT WAS THEN INDICATED THAT THE SITE PLANNED TO SWAP THE PATIENT SIDE CART WITH ONE FROM A DIFFERENT SYSTEM, NOTING THAT THE ERROR PATTERN WAS ATYPICAL BECAUSE THE INITIAL ERROR APPEARED ON THE BOOM AND THEN MOVED TO ARM 4 WITH A 319 FAULT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90187 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-45 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1