BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16252793 · Received January 27, 2023

    Report

    Report Number
    2955842-2023-10357
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    December 30, 2022
    Report Date
    December 30, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECTION AND CONFIRMED THE ISSUE. THE FSE PERFORMED GIMBAL CALIBRATION INCLUDING COUNTERBALANCE AND SINGLE RANGE TO RESOLVE THE ISSUE. NO PART REPLACEMENT REQUIRED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING DRIFTING ISSUE WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE ALLEGED DRIFTING ISSUE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FSE'S FIELD EVALUATION. THE FSE CONFIRMED THE ISSUE AND PERFORMED GIMBAL CALIBRATION INCLUDING COUNTERBALANCE AND SINGLE RANGE TO RESOLVE THE ISSUE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE LEFT MASTER TOOL MANIPULATOR (MTML) WAS DRIFTING UNINTENTIONALLY AFTER THE START OF THE PROCEDURE. THE DRIFTING ISSUE COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION MODEL # IS NOT APPLICABLE. FIELD IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION INITIAL REPORTER NAME AND ADDRESS: IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER FELT THE WRIST OF THE LEFT MASTER TOOL MANIPULATOR (MTML) WAS DRIFTING UNINTENTIONALLY. THERE WAS NO OBSTRUCTION WITH THE INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE INSTRUMENT INSTALLED ON THE ARM WAS NOT MOVING UNINTENTIONALLY. THE CUSTOMER DID NOT TAKE ANY ACTIONS AND WAS ABLE TO CONTINUE THE PROCEDURE WITH ALL 4 ARMS. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. THE PATIENT HAD NO INJURY/HARM. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616523 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-12 N/A 00886874110744

    Patients

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