BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 21709568 · Received March 27, 2025

    Report

    Report Number
    2955842-2025-11783
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 3, 2025
    Report Date
    January 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) FOR FAILURE ANALYSIS INVESTIGATION. THE UNITS WERE ANALYZED AND THE FOLLOWING INFORMATION WAS OBTAINED: HRSV1: IN ARTEMIS, THE 119 ERROR WAS FOUND INDICATING THE FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE HRSV DID NOT DISPLAY ANY IMAGE, TOTALLY BLACK SCREEN. SUCCESSFULLY REPLICATED THE REPORTED COMPLAINT. HRSV2: IN ARTEMIS, ERROR 119 WERE FOUND INDICATING FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THERE ARE TWO HRSVS RETURNED FROM THE SITE AND THE ISSUE WAS REPLICATE ON THE LEFT HRSV. THE UNIT WAS INSTALLED ONTO THE GOLDEN SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED (CLEAR IMAGE DISPLAYED). THE SYSTEM RAN THROUGH 10 POWER CYCLES, AND NO RELATED ERRORS/FAULTS WERE TRIGGERED. THE UNIT WAS FOUND TO BE FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE HIGH RESOLUTION STEREO VIEWER (HRSV) LOST VISION IN THE LEFT EYE. THE USER CONFIRMED THAT THE VISION SIDE CART'S TOUCHSCREEN DISPLAY WAS STILL VISIBLE IN BOTH EYES. THE USER ATTEMPTED TO RESTART THE SYSTEM MULTIPLE TIMES, BUT THE ISSUE PERSISTED. THE TSE SUGGESTED THAT THE USER REMOVE THE CONNECTION FROM THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) BUT THE USER REFUSED TO FOLLOW. THE USER CONTINUED WITH THE PROCEDURE USING THE SAME SYSTEM CONFIGURATION AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING ONLY ONE EYE AND A FIELD SERVICE ENGINEER REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS NOT DELAYED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469832 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-14 N/A 00886874115374

    Patients

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