BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 21713414 · Received March 27, 2025

    Report

    Report Number
    2955842-2025-11820
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 6, 2025
    Report Date
    March 6, 2025
    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
    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 HRSV MONITORS WITH LED MONITORS TO SOLVE THE ISSUE. 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 MONITORS. COMPLAINTS ARE TRACKED VIA THE QMS PROCESSES PER WI 859369 (QUALITY DATA REVIEW MEETINGS).

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. BOTH HIGH RESOLUTION STEREO VIEWER (HRSV) MONITORS HAVE BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) AND THE REPORTED ISSUE WAS NOT REPLICATED OR CONFIRMED. IN SYSTEM LOGS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MONITORS WERE INSTALLED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. STARTED UP WITHOUT ANY ERRORS. THE IMAGE QUALITY WAS SHARP, NO NOISE, AND WAS NOT TINTED. DID NOT NOTICE ANY WHITE LINES. THEN, 10 POWER CYCLES WERE PERFORMED AND THE SYSTEM WORKED NORMALLY WITHOUT ANY ISSUES. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. THE ROOT CAUSE IS UNABLE TO BE DETERMINED SINCE FAILURE ANALYSIS FOUND NO ISSUES RELATED TO THE REPORTED EVENT. THE HRSV MONITORS WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR ADDITIONAL TESTING AND FOR POTENTIAL REPAIR.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS ABLE TO BE COMPLETED ROBOTICALLY WITH THE ORIGINAL SYSTEM, DESPITE THERE BEING VISION IN ONLY ONE EYE AT THE SURGEON'S CONSOLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THERE WAS A WHITE LINE IN THE VISION OF THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE INTUITIVE TECH SUPPORT ENGINEER (TSE) SUGGESTED TO POWER CYCLE THE SYSTEM, IF POSSIBLE. REPORTEDLY AFTER, THE POWER CYCLE THE HRSV LOST VISION IN ONE EYE. A HARD POWER CYCLE WAS PERFORMED, BUT THE ISSUE REMAINED. THE PROCEDURE WAS BEING COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415586 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-15 N/A 00886874115374

    Patients

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