BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24921571 · Received April 20, 2026

    Report

    Report Number
    2955842-2026-22134
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. FSE FOUND THAT BOTH OPTICAL FIBERS HAD BEEN HEATED AND MELTED AND REPLACED THE FIBER OPTIC CABLES (FOC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE FOC WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OTHER UROLOGY SURGICAL PROCEDURE, THE BLUE FIBER CABLE (BFC) AT THE PATIENT SIDE CART (PSC) WAS BURNT AND THE ISSUE WAS DISCOVERED BEFORE DOCKING THE ROBOT. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER USED ANOTHER DV SYSTEM TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257437 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-43 N/A 00886874115404

    Patients

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