BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15136131 · Received July 29, 2022

    Report

    Report Number
    2955842-2022-13264
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 1, 2022
    Report Date
    July 1, 2022
    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
    NL
    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 COMPLAINT. FSE CONFIRMED THE REPORTED ISSUE. TO CORRECT THE ISSUE, FSE REPLACED THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU). FOLLOWING SERVICE THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT, HOWEVER, DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE RETURNED IESU HAS BEEN EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED. AN ISI TECHNICAL SUPPORT ENGINEER REVIEWED THE SYSTEM LOGS AT THE TIME OF THE CALL INTO TECHNICAL SUPPORT AND CONFIRMED THE REPORTED ERRORS (C-38, C-37, M-11, AND C-43). SEVERAL HOURS LATER TSE CHECKED LOGS AND NOTICED THAT THE CUSTOMER USED A VISION SIDE CART FROM THEIR OTHER SYSTEM (SL0161) TO FINISH THE TOTAL GASTRECTOMY PROCEDURE ON (B)(6) 2022 SUCCESSFULLY. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO A VISION SIDE CART FROM ANOTHER SYSTEM AFTER THE START OF THE PROCEDURE DUE TO AN ISSUE WITH THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, H3, H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPRODUCE THE REPORTED FAILURES (ERROR C-38 AND C-00). DURING INVESTIGATION THE IESU HAD A C-34 ERROR APPEAR ON START-UP AND ALSO APPEARED WHEN ON THE SYSTEM. THE IESU WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER TO BE REPAIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) SUDDENLY DISPLAYED AN ERROR C-38. INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND NOTED ERRORS C-38, C-37, M-11, AND C-43. TSE INSTRUCTED THE CALLER (NURSE) TO POWER CYCLE THE VIO IESU ONLY. AFTER DOING SO, THE ERBE DISPLAYED AN ERROR C-00. TSE INFORMED THE CALLER THAT THE VIO VIO IESU WOULD NEED TO BE REPLACED. TSE ASKED IF CALLER HAD A Y-CABLE TO CONNECT EXTERNAL IESU TO THE SYSTEM OR IF THEY HAD AN OPTION TO SWITCH VISION SIDE CART (VSC) WITH THEIR OTHER SYSTEM. CALLER STATED THEY HAVE THE Y-CABLE AND WILL CONNECT EXTERNAL IESU TO THE VSC AND CONTINUE SURGERY WITH THIS SYSTEM. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. CUSTOMER CALLED AGAIN TO REQUEST ASSISTANCE WITH THE CONNECTION OF THE EXTERNAL IESU AS IT WAS NOT WORKING AFTER THEY CONNECTED IT. TSE FOUND THAT CUSTOMER DID NOT HAVE CORRECT Y-CABLE. TSE CHECKED LOGS AND NOTICED THAT CUSTOMER USED VSC FROM THEIR OTHER SYSTEM (SL0161) TO FINISH THE CASE SUCCESSFULLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    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
    1411898 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

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