BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15407683 · Received September 12, 2022

    Report

    Report Number
    2955842-2022-13969
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 15, 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
    TX, 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 COMPLAINT. THE FSE ARRIVED ON SITE TO TROUBLESHOOT AND FOUND THAT THE PATIENT SIDE CART (PSC) CARD CAGE FILTER WAS CLOGGED. THE FSE CLEANED THE FILTER, POWERED ON THE SYSTEM, AND MONITORED THE BOARD TEMPERATURE. SYSTEM NO LONGER HAD ANY SIGNS OF OVERHEATING. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A PROCEDURE LOG REVIEW CONFIRMED THE HYSTERECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO TRADITIONAL LAPAROSCOPY AFTER THE START OF THE PROCEDURE DUE TO SYSTEM OVERHEATING. 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 CONVERSION/ABORTION. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION AND THE ADVERSE EVENT OR PRODUCT PROBLEM WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE DEVICE EXPIRATION DATE FOR THE SUSPECTS MEDICAL DEVICE WAS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD AN OVERHEATING MESSAGE AND IT SHUT DOWN. PRIOR TO CALLING, SITE TOOK THE FRONT BEZEL OFF OF THE VISION SIDE CART (VSC) AND RINSED THE BLACK FILTER WITH WATER. THE SITE PUT THE BEZEL COVER BACK ON BUT LEFT THE FILTER OFF. THE SITE WAS ABLE TO POWER UP THE SYSTEM SUCCESSFULLY AND CONTINUED WITH THE CASE. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED CUSTOMER TO OPEN THE BACK DOOR OF THE VSC TO PROMOTE BETTER AIRFLOW. THEN, CUSTOMER CALLED BACK TO REPORT THAT THE SYSTEM HAD SHUT DOWN AGAIN DUE TO THE SYSTEM OVERHEATING. CUSTOMER CLEANED THE VSC FILTER AND OPENED THE VSC DOOR FOR AIRFLOW BUT SYSTEM SHUTDOWN. THE TSE VIEWED SYSTEM EVENT LOGS AND FOUND THAT THE BOARD THAT WAS OVERHEATING WAS LOCATED IN THE PATIENT SIDE CART (PSC). THE TSE ADVISED CUSTOMER THAT THEY CAN ALLOW THE PSC TO COOL DOWN THEN CONTINUE OR SWAP TO ANOTHER PSC. CUSTOMER LOOKED TO BRING IN ANOTHER PSC. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT HARM. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 25-AUG-2022: THE ROBOTICS COORDINATOR CONFIRMED THAT THE PSC WAS NOT SWAPPED OUT. INSTEAD, THE SURGEON DECIDED TO CONVERT TO TRADITIONAL LAPAROSCOPIC SURGERY. THE ISSUE WAS DISCOVERED ABOUT 10 MINUTES INTO THE PROCEDURE AND THE SYSTEM POWERED UP WITHOUT ERRORS. THE SURGEON WAS NEVER ABLE TO SEE THROUGH THE HIGH STEREO RESOLUTION VIEWER (HRSV) AND GO INTO THE FOLLOWING MODE. THE PATIENT-RELATED INFORMATION COULD NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591714 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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