BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14597474 · Received June 3, 2022

    Report

    Report Number
    2955842-2022-12015
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 6, 2022
    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
    WY, 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 COMPLAINT. FSE REVIEWED SYSTEM LOGS AND DISCOVERED THAT THE SYSTEM WAS NEVER FULLY SHUT DOWN AFTER PREVIOUS PROCEDURE USAGE AND HAD BEEN CONTINUALLY ON FOR AN EXTENDED TIME. FSE RECOMMENDED TO THE CUSTOMER TO PROPERLY SWITCH THE SYSTEM OFF AT THE END OF EACH DAY. FSE INFORMED THE CUSTOMER THAT DAMAGE MAY OCCUR TO BOARDS AND/OR COMPONENTS IF THE SYSTEM IS LEFT ON FOR LONG PERIODS OF TIME. THE FSE SYSTEM TESTING CONFIRMED NO FUNCTIONAL ISSUE, CONFIRMED THAT THE PATIENT SIDE CART IS WITHIN SPECIFICATION. SYSTEM WAS VERIFIED READY FOR USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE AND ISI FSE'S INVESTIGATION THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED DUE TO UNSATISFACTORY PROCEDURAL SETUP AFTER THE START OF THE PROCEDURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE SURGEON WAS HAVING TROUBLE POSITIONING THE SYSTEM FOR SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE SURGEON FELT THAT THE DA VINCI SYSTEM WAS NOT DEPLOYING FOR DOCKING CORRECTLY. CUSTOMER WAS SETTING UP FOR A CHOLECYSTECTOMY. THE ISSUE WAS EXPERIENCED APPROXIMATELY 30 MINUTES AFTER SURGICAL PORT PLACEMENT. THE CUSTOMER STATED THAT THE PATIENT SIDE CART (PSC) BOOM WAS FACING THE WRONG DIRECTION AND WOULD NOT STERILE STOW PROPERLY. TSE WALKED CUSTOMER THROUGH A HARD REBOOT. THE SYSTEM BOOTED UP SUCCESSFULLY. TSE REVIEWED LOGS AND FOUND NO APPARENT ERRORS RELATED TO WHAT WAS DESCRIBED. THE SURGEON STATED THAT THE PSC BOOM WAS FACING THE WRONG WAY FOR AN ABDOMINAL PROCEDURE. TSE ASKED THE CUSTOMER IF THEY COULD MANUALLY REPOSITION USING SYSTEM JOYSTICKS. THE CUSTOMER DID SO; HOWEVER, THE SURGEON WASN'T HAPPY WITH THE SYSTEM SETUP AND SAID IT WAS TOO CLOSE TO VERTICAL LIMITS. TSE ASKED IF THEY COULD ADJUST VERTICAL BOOM POSITION OR THE PATIENT CLEARANCE BUTTONS, BUT THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC PROCEDURE. NO FURTHER ASSISTANCE WAS REQUIRED. THERE WAS NO REPORTED INJURY. THE CUSTOMER WAS UNSURE OF WHAT THE CONTRIBUTING FACTORS THAT CAUSE THE ISSUE. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WAS REQUESTED, HOWEVER THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557230 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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