BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24539286 · Received March 6, 2026

    Report

    Report Number
    2955842-2026-15232
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    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 REPLACED THE AXES CONTROLLER PLATFORM (ACP), AXES CONTROLLER PLATFORM DUAL (ACPD), AXES CONTROLLER PLATFORM BACKPLANE (ACPB) DUE TO RECOVERABLE AND NON-RECOVERABLE ERRORS 307 AND 319. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS NOT RECEIVED THE ACP, ACPD, OR ACPB FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED. THE ROOT CAUSE OF ERROR 319 POINTS TO NODE 203 IS NOT PRESENT AT STARTUP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A NON-RECOVERABLE FAULT 307 OCCURRED. THE USER ATTEMPTED A HARD POWER CYCLE, BUT THE ISSUE WAS NOT RESOLVED. TSE REVIEWED AND CONFIRMED THE ERROR IN THE LOGS. THE PROCEDURE WAS COMPLETED AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495316 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1