BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23397957 · Received October 27, 2025

    Report

    Report Number
    2955842-2025-43025
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    July 23, 2025
    Report Date
    March 1, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED, AND THE REPORTED PROBLEM WAS NOT CONFIRMED OR REPLICATED. IN THE SYSTEM LOGS, NO DATA WAS FOUND TO INDICATE THE FAILURE OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, NO ISSUES WERE FOUND RELATED TO THE REPORT. THE PMSC WAS INSTALLED ONTO THE GOLDEN SYSTEM, ALL THE OUTPUT AND INPUT PORT WERE TESTED AND HAD GOOD IMAGE, WITH NORMAL IMAGE ON LEFT EYE. THE GOLDEN SYSTEM WAS SET TO RUN 10 POWER CYCLES AND SITTING IDLE FOR 45 MINUTES. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. THE SURGEON BACK PLANE (SBP) BOARD WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED BUT NOT REPLICATED. UPON VISUAL INSPECTION, NO OBVIOUS DAMAGE WAS OBSERVED; HOWEVER, THE UNIT WAS RETURNED WITHOUT TWO SMALL FORM-FACTOR PLUGGABLE (SFP) TRANSCEIVERS INSTALLED ON THE SURGEON BACKPLANE. DUE TO THE MISSING SFP TRANSCEIVERS, THE UNIT COULD NOT INITIALLY BE INSTALLED INTO THE GOLDEN SYSTEM TO VERIFY THE REPORTED ISSUE. TO PROCEED WITH TESTING, TWO KNOWN-GOOD SFP TRANSCEIVERS FROM THE GOLDEN SYSTEM WERE USED. DURING INSTALLATION, ONE TRANSCEIVER COULD NOT BE FULLY SEATED IN THE J43 SOCKET. FURTHER INSPECTION REVEALED DAMAGE TO THE J43 SOCKET, PREVENTING PROPER INSERTION OF THE SFP MODULE. ADDITIONALLY, THE TWO VSL BOARDS WERE ANALYZED AND THE REPORTED ISSUE WAS NOT CONFIRMED OR REPLICATED. A REVIEW OF SYSTEM LOGS FOUND NO EVIDENCE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ABNORMALITIES OR DAMAGE WERE IDENTIFIED THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE UNITS WERE INSTALLED IN A KNOWN-GOOD SYSTEM, WHERE THEY FUNCTIONED AS EXPECTED. THE SYSTEM UNDERWENT A 10-MINUTE SINE CYCLE TEST, 10 POWER CYCLES, AND WAS LEFT IDLE FOR FIVE DAYS. FOLLOWING COMPLETION OF TESTING, THE SYSTEM ERROR LOGS WERE REVIEWED, AND NO RELATED ERRORS WERE DETECTED. VIDEO TESTING CONFIRMED GOOD IMAGE QUALITY IN BOTH EYES WITH NO ANOMALIES OBSERVED FOR BOTH VSL BOARDS. ONCE THE TESTING WAS COMPLETED, THE J43 SOCKET ON SBP BOARD WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A MECHANICAL DAMAGE FROM THE J43 SOCKET LOCATED ON SBP BOARD, LEADING TO IMPROPER CONNECTIONS ON SPB BOARD. THIS ISSUE CAN BE RESOLVED BY REPLACING THE SPB BOARD FROM SSC.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR WAS ANALYZED, AND THE REPORTED FAILURE WAS CONFIRMED AND REPLICATED. THE SYSTEM LOGS IDENTIFIED ERROR 119, INDICATING THAT THE FAILURE OCCURRED IN THE FIELD. A VISUAL INSPECTION DID NOT REVEAL ANY CONDITIONS DIRECTLY RELATED TO THE REPORTED COMPLAINT. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM, WHERE ERROR 119 WAS GENERATED DURING POWER CYCLING; HOWEVER, THE INTERMITTENT LOSS OF THE LEFT EYE DISPLAY COULD NOT BE VISUALLY REPRODUCED DURING TESTING. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN ELECTRICAL COMPONENT ISSUE WITHIN THE LEFT HRSV MONITOR. THIS ISSUE CAN BE RESOLVED BY REPLACING THE HRSV OR USE A DIFFERENT SURGEON CONSOLE TO COMPLETE THE PROCEDURE.

    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 HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR DUE TO SPORADIC FAILURES OF THE LEFT EYE ON THE SURGEON SIDE CONSOLE (SSC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE HRSV.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER INDICATED THE ISSUE OCCURRED PREVIOUSLY BUT COULD NOT PROVIDE EXACT EVENT DATE. PER USER, THE LEFT EYE ON THE SURGEON SIDE CONSOLE (SSC) WAS BLUE AND THE CUSTOMER SWAPPED TO SECOND SSC TO PROCEED WITH THE CASE AS PLANNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THESE INCIDENTS OCCURRED ON (B)(6),2025, (B)(6), 2025, (B)(6), 2025, AND (B)(6), 2025. EACH TIME, SITE CONTACTED FOR SUPPORT FROM INTUITIVE TECH. THE ISSUE OCCURRED ALWAYS DURING THE ONGOING SURGERY, SOMETIMES EVEN DURING THE PROSTATE RETRIEVAL PROCESS. THERE WAS A TIME WHEN THE SURGEON WAS NO LONGER AT THE CONSOLE BECAUSE HE HAD TO COLOR THE PROSTATE FOR THE PATHOLOGISTS. SITE COULDN'T IDENTIFY ANY CONNECTION TO POSSIBLE ERRORS ON THE PART OF THE SURGICAL TEAM TO RULE ANYTHING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308752 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-26 N/A 00886874110744

    Patients

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