BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24526135 · Received March 5, 2026

    Report

    Report Number
    2955842-2026-15199
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    May 28, 2025
    Report Date
    March 5, 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
    TX, US
    Reporter Occupation
    NURSE
    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 FIBER OPTIC CABLE (FOC) DUE TO ERROR 319. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE FOC FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERRORS AND A MESSAGE TO RESTART THE SYSTEM. THE CUSTOMER STATED THEY PRESSED RETRY AND RESTART, BUT THE ERROR KEPT RETURNING OVER AND OVER. THE CUSTOMER STATED THEY ABORTED THE CASE BECAUSE OF THE SURGEON AND NOT THE SYSTEM. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619193 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