BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18116692 · Received November 10, 2023

    Report

    Report Number
    2955842-2023-20095
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 20, 2023
    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
    CH
    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. THE FSE WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED PROBLEMS. THE FSE CONFIRMED A DEFECTIVE LEFT MTM ARM ON SSC2. AFTER REPLACEMENT, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE REPLACED MTM ARM INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED MASTER TOOL MANIPULATOR (MTM) 2 INVOLVED WITH THIS COMPLAINT. THE MTM2 WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED COMPLAINT. HOWEVER, THE ISSUE COULD BE CONFIRMED AS HAVING OCCURRED VIA THE FIELD ERROR LOGS. A VISUAL INSPECTION WAS PERFORMED. THE MTM2 WAS INSTALLED ONTO THE SYSTEM AND POWERED UP THE SYSTEM. A SINE CYCLE AND A TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. ADDITIONALLY, ALL THE REQUIRED TESTS WERE PERFORMED AND PASSED. THERE WAS NO PROBLEM DETECTED WITH THIS PRODUCT. THE REPORTED COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING A DUAL SURGEON CONSOLE (SSC) SETUP, THE USER OBSERVED A VIRTUAL POINTER ON THE DISPLAY SCREEN. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE CONFIRMED THAT THE REPORTER WAS NOT PRESENT AT THE TIME OF THE EVENT AND WAS JUST INFORMED OF THE ALLEGED ISSUE. TSE WAS INFORMED BY THE REPORTER THAT THE SYSTEM POWERED ON WITHOUT ANY ERROR. TSE RECOMMENDED TO TROUBLESHOOT BY REMINDING THE USER TO REFRAIN FROM CONTROLLING THE SECOND SSC (SSC2). REPORTER STATED THAT NO ONE WAS TOUCHING SSC2 AND THAT THE VIRTUAL POINTER APPEARED AUTOMATICALLY. TSE RECOMMENDED TO PERFORM A HARD POWER CYCLE AND GRIP THE MASTER TOOL MANIPULATOR (MTM) ARMS SEVERAL TIMES WHEN POWERING OFF. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PROCEDURE STARTED WITH A DUAL SSC SETUP. ONE OF THE MTM ARM ON SSC2 WAS UNABLE TO MOVE. THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED USING SSC1. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108622 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES