BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19582101 · Received June 21, 2024

    Report

    Report Number
    2955842-2024-15990
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 23, 2024
    Report Date
    May 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    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 FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. HOWEVER, THE FSE NOTED THAT THE CONSOLE HAD ERROR 417'S AND WOULD SHUT OFF AFTER 10 MINUTES OF OPERATION. THE FSE REPLACED THE REDUNDANT MEDICAL GRADE POWER SUPPLY (RMGPS) IN ACCORDANCE WITH ISI PROCEDURES. THE FSE ALSO IDENTIFIED THAT THE OUTLET THAT WAS BEING USED WAS DAMAGED. THE FSE RELOCATED THE POWER CORD TO ANOTHER OUTLET AND INFORMED THE CUSTOMER TO NOTIFY FACILITIES TO INSPECT THE ROOM OUTLETS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE RMGPS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. DURING IN-HOUSE TESTING, THE RMGPS FAILED WITH AN ERROR 417 AND THERE WAS NO GREEN LED LIT DURING POWER UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE SURGEON SIDE CART (SSC) WAS LOSING POWER AND SHUTTING OFF WHILE THE SYSTEM WAS IN USE. THE SYSTEM LOGS SHOWED COMMUNICATION ERRORS FOLLOWED BY MULTIPLE NON-RECOVERABLE FAULTS. PRIOR TO CALLING THE TSE, THE CUSTOMER RELOCATED THE SURGEON SIDE CONSOLE (SSC) POWER CABLE TO ANOTHER WALL OUTLET AND POWER WAS RESTORED TO THE SSC. THE SYSTEM POWERED BACK ON SUCCESSFULLY, BUT THE SSC LOST POWER AGAIN SHORTLY AFTER. THE CUSTOMER DID NOT HAVE ANOTHER SSC AVAILABLE BECAUSE ALL OTHER SYSTEMS WERE IN USE AT THE TIME. THE SURGEON ELECTED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY TO COMPLETE THE PROCEDURE. THE CUSTOMER REQUESTED FOR AN ISI FIELD SERVICE ENGINEER (FSE) TO SERVICE THE SYSTEM. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT ADDITIONAL PORTS WERE PLACED AND ADDITIONAL UNSPECIFIED DISPOSABLE SUPPLIES WERE USED. THE CUSTOMER DID NOT ANTICIPATE THE POSSIBILITY OF THE CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY UNTIL THE ROBOT BEGAN GIVING AN ERROR MESSAGE. THE PATIENT TOLERATED THE CHANGE IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201726 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES