BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24773037 · Received April 3, 2026

    Report

    Report Number
    2955842-2026-20337
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 17, 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
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ISI FOLLOWED UP WITH INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS COMMUNICATION ERRORS 170 AND 31089. THE SYSTEM WAS NOT IN USE. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED THE REPORTED COMMUNICATION ERRORS ON THE SYSTEM AND REPLACED THE COMMON COMPUTE CONTROLLER (CCC), BLUE FIBER PIGTAILS CABLE AND BLUE FIBER CABLE PORTS TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (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

    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 DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT ERRORS OCCURRED ON THE SYSTEM. THE CSR MENTIONED THAT THE SYSTEM WAS TURNED ON WITHOUT ERRORS ONCE, AND THEN IT WENT INTO ERROR MODE. THE CSR MENTIONED THAT THE ISSUE WAS SPORADIC. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62851 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-45 N/A 00886874119716

    Patients

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