BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21704720 · Received March 27, 2025

    Report

    Report Number
    2955842-2025-11777
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 28, 2025
    Report Date
    February 28, 2025
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE. D15 IS THE CONCLUSION CODE BASED ON FAILURE ANALYSIS FINDINGS.

    Additional Manufacturer Narrative · 0

    THE MTM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE MTM WAS THEN INSTALLED ONTO A PFTP WHERE A RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE J23 COUNTERBALANCE SPRING CABLE ON AXIS 2 WAS INSPECTED AND NO FAULTS COULD BE IDENTIFIED. ROOT CAUSE IS ATTRIBUTED TO THE J23 COUNTERBALANCE SPRING CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE MASTER TOOL MANIPULATOR LEFT (MTML) DRIFTED DURING THE PROCEDURE. TSE ASKED IF THE SURGEON WAS ENGAGED WITH THE HIGH-RESOLUTION STEREO VIEWER (HRSV) WHEN THE DRIFT OCCURRED. CUSTOMER COULD NOT CONFIRM IF THAT WAS THE SITUATION OR NOT. CUSTOMER POWER CYCLED THE SYSTEM AND SURGEON MOVED TO THE OTHER SURGEON SIDE CONSOLE (SSC). ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SITE TO FURTHER TROUBLESHOOT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL FOLLOWED UP AND GATHERED THE FOLLOWING INFORMATION: THE TYPE OF DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED BY THE SURGEON IS SIGMOID COLON RESECTION. THE TIME OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED WAS 0938 START TIME ON (B)(6) 2025. PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. YES, PRIOR TO THE ISSUE WHICH WAS LATER ON DURING THE PROCEDURE. THE ORIGINAL CONSOLE WAS USED WAS SURGEON SIDE CONSOLE (SSC) WAS SK6253. PATIENT DEMOGRAPHIC 48-YEAR-OLD MALE, DATE OF BIRTH (DOB) (B)(6) 1977, WEIGHT: 93.9KG., BODY MASS INDEX (BMI): 29.7, HEIGHT: 177.8CM, ETHNICITY: NON-HISPANIC, RACE: WHITE. RELEVANT TEST RESULTS -PREOP LABS DRAWN BUT WERE NOT RELEVANT. RELEVANT PATIENT HISTORY INCLUDED MEDICAL HISTORY OF DIVERTICULITIS AND DIVERTICULITIS OF COLON.

    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
    2373915 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-27 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES