BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 22288641 · Received June 18, 2025

    Report

    Report Number
    2955842-2025-26281
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. TO HELP REDUCE THE REPORTED INSTRUMENT SENSING ISSUE, THE FSE SHOWED THE CUSTOMER HOW TO INSTALL A STERILE ADAPTER (SA) AND INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM), AND HOW TO VISUALLY INSPECT THE USM CARRIAGE AND SA ALONG WITH INSTRUMENT FOR DEFECT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) AN ISSUE HAPPENED ON 5/21/2025. THE CUSTOMER STATED DURING SURGERY THE INSTRUMENT INSTALLED ON ARM 3 (MONOPOLAR CURVED SCISSORS) HAS DISENGAGED BY ITSELF. THE CUSTOMER CONFIRMED ARM 3 WAS STILL DOCKED TO THE PATIENT, BUT THE CANNULA MOVED INSIDE THE BODY OF PATIENT WITHOUT IMPACT. THE CUSTOMER WANTED TO KNOW IF FURTHER TROUBLESHOOTING WAS NECESSARY. TSE CHECKED LOGS AND FOUND ERROR 31009 POINTING TO INSTRUMENT SENSORS MISSING ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE TSE INFORMED THE CUSTOMER THAT ERROR HAPPENED WHEN THE INSTRUMENT OR STERILE ADAPTER WAS NOT PROPERLY INSTALLED OR DEFECTIVE. THE TSE REVIEWED HISTORY LOGS AND FOUND ERROR 282 DURING THE LAST SURGERY POINTING TO ONE OR MORE TOOL SENSORS WERE NOT DETECTED ON USM3. THE TSE INFORMED THE CUSTOMER MOST LIKELY USM3 NEEDED TO BE REPLACED TO GUARANTEE INTERRUPTING FREE PROCEDURE IN THE FUTURE AND TO AVOID ADVERSE PROCEDURE OUTCOMES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE HIGH RESOLUTION STEREO VIEWER OF THE SURGEON CONSOLE WHEN THE SURGEON WANTED TO USE THE SCISSORS. THE FAILURE WAS RELATED TO A STATIC INSTRUMENT AND IT WENT UP WHEN THE SURGEON WANTED TO USE IT. THE SCISSORS WENT UP AS WELL AS THE TROCAR. NO LEFT-RIGHT MOVEMENT. THE PROBLEM WAS ENCOUNTERED ONCE. THE PROBLEM WAS RESOLVED BY PUTTING THE TROCAR BACK IN PLACE ALONG WITH THE SCISSORS ON THE ROBOT ARM. THE DEVICE WAS INSPECTED AS USUAL AND NOTHING UNUSUAL WAS OBSERVED. APPARENTLY, THE PROBLEM DID NOT COME FROM THE SCISSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854480 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-43 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES