BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17778055 · Received September 19, 2023

    Report

    Report Number
    2955842-2023-18560
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 24, 2023
    Report Date
    August 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVANCED TECHNICAL REVIEW (RESULTS): SYSTEM LOG INVESTIGATION: A REVIEW OF THE LOGS FOR THE SYSTEM SK3231 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS (AFA) ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THERE WERE THREE PROCEDURES TAKEN PLACED ON (B)(6) 2023. USMS WERE NOT DISABLED IN ANY OF THESE PROCEDURE ON (B)(6) 2023.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED NO ERRORS; HOWEVER, IT WOULDN'T ENGAGE THE STERILE ADAPTER. THE UNIT WAS ALSO TESTED ON THE TEST PLATFORM, AND IT PASSED ALL TESTS. UPON FURTHER INVESTIGATION, THERE WAS NO FLUID INTRUSION OR PHYSICAL DAMAGE. THE LOG POINTS TO AN ERROR 22020 ON DEGREE OF FREEDOM (DOF) 6 AND 8. AS A FIX, THE TOP PLATE, DOF 6/8 GEARBOX, AND ROTOR WILL BE REPLACED. .

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ENGAGEMENT ISSUES UNIVERSAL SURGICAL MANIPULATOR (USM) 4. INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TRIED TO VIEW SYSTEM LOGS, BUT SYSTEM WASN'T CONNECTED TO ONSITE DURING THE CALL. THE SURGEON IS WORKING AROUND THE ISSUE AND CONTINUING WITH THE CASE. 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 PROCEDURE WAS COMPLETED ROBOTICALLY. IT WAS UNKNOWN IF THE INSTRUMENTS ENGAGED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89387 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A 00886874110720

    Patients

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