BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23216489 · Received October 4, 2025

    Report

    Report Number
    2955842-2025-40708
    Event Type
    Malfunction
    Date Received
    October 4, 2025
    Date of Event
    September 16, 2025
    Report Date
    September 16, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE PERSONALITY MODULE AUDIO / VIDEO (PMAV) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN THE SYSTEM LOG, ERROR CODE 23 WAS FOUND TO INDICATE THE FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND RELATED TO THE REPORTED ISSUE. THE PMAV WAS INSTALLED ONTO THE GOLDEN TESTING SYSTEM, UPON POWER ON, THE SYSTEM FAILED WITH ERROR 307, THE PMAV WAS NOT PRESENT. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE CAN BE ATTRIBUTED TO A FAULT OF AN ELECTRONIC COMPONENT OR MODULE ON THE VIDEO BRANCH (VBR) BOARD WITHIN THE AFFECTED PMAV. THIS ISSUE CAN BE RESOLVED BY REPLACING THE AFFECTED PMAV VIA FSE SERVICE OR SWITCHING TO A BACKUP SYSTEM.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE AND REPLACED THE PERSONALITY MODULE AUDIO VIDEO (PMAV). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE UNIT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. 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 DA VINCI-ASSISTED UROLOGY NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE SYSTEM REPORTED ERROR 23. TSE GUIDED THE CUSTOMER TO POWER CYCLE THE SYSTEM AND RESEAT THE BLUE FIBER CABLE (BFC); HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651708 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

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