BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18415673 · Received December 28, 2023

    Report

    Report Number
    2955842-2023-21536
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE VIDEO PROCESSOR (VP) AND FIBER CABLE WAS REPLACED DUE TO ERROR 23, 40, 40084, 48259. 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. THE VP WAS ANALYZED, AND THE REPORTED FAILURE WAS REPLICATE. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND RUNNING VIDEO TEST, 10 MINUTES SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. DURING THE TEST, THE TECHNICIAN REPLICATED THE REPORTED FAILURE. DURING TROUBLESHOOTING TECHNICIAN FOUND THE DUAL WINDOW APPLIANCE (DWA) BOARD WAS THE CAUSE OF THE ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER-REPORTED ISSUE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO STARTING THE PROCEDURE - PRE-ANESTHESIA. THERE WAS A RECOVERABLE FAULT. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM WITH NO ISSUE NOTED. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER WAS CONTACTED FOR TROUBLESHOOTING, AND FULL TROUBLESHOOTING WAS COMPLETED. THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE ROBOTICALLY WHILE HAVING SOME RECOVERABLE FAULT ERRORS. THE PROCEDURE WAS NOT CONVERTED. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE SITE HAD RECOVERABLE FAULT WHILE SETTING UP SYSTEM. THE STAFF REQUESTED SYSTEM LOGS BE CHECKED. LOGS SHOWED ERROR 23 AND 40084 POINTING TO FIBER CABLE COMMUNICATION TO VIDEO PROCESSOR (VP). THE INTUITIVE TECHNICAL SERVICE ENGINEER (TSE) ASKED OR STAFF TO POWER DOWN SYSTEM AND DISCONNECT/RECONNECT BLUE FIBER CABLE CONNECTIONS. TSE INFORMED CUSTOMER THAT FIBER CABLE IN BOTTOM PORT SHOULD BE DISCONNECTED AND RECONNECTED. OR STAFF HUNG UP TO CHECK CONNECTIONS. OR STAFF WAS CONTINUING WITH SYSTEM SETUP. THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED BACK ASKING QUESTIONS ABOUT THE ISSUE. CSR STATED SITE HAD SAME ISSUE HAPPEN DURING CASE. THE STAFF HAD RESEATED ALL THE FIBER CONNECTIONS AND CHANGED OUT ONE DUE TO IT BEING FRAYED ON ONE END AND YOU COULD SEE METAL. THE STAFF CONTACTED TECH SUPPORT AFTER THE SYSTEM SHUTOFF DURING A PROCEDURE. THE CALLER INDICATED THEY'VE PREVIOUSLY REPLACED THE FIBER CABLE BETWEEN THE PATIENT SIDE CART (PSC) AND THE CORE. LOGS SHOW THE ISSUE REMAINS ON THE FIBER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    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
    1401433 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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