BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 18716129 · Received February 15, 2024

    Report

    Report Number
    2955842-2024-11431
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 17, 2024
    Report Date
    January 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE TEST DROVE THE SYSTEM AND COULD NOT REPLICATE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). BASED ON REVIEW OF THE STATE LOGS, SHAPE LOGS, AND VISION PROBE FEED BY AN ION SYSTEM ANALYST AND AN ION MEDICAL IMAGING ENGINEER, AT TWO SEPARATE OCCURRENCES DURING THE PROCEDURE, THE VISION PROBE WAS NOT DETECTED AS BEING FULLY SEATED PRIOR TO THE USER BEGINNING DRIVING. THE STRIPE DETECT ALGORITHM PROCESSES AND SENDS THE UPDATED ORIENTATION TO THE USER INTERFACE ONCE THE PROXIMAL PROBE SENSOR SIGNAL DROPS, INDICATING THAT THE PROBE IS FULLY SEATED. FROM THE LOGS, IT WAS OBSERVED THAT THE USER BEGAN DRIVING BEFORE THE PROXIMAL PROBE SENSOR SIGNAL DROPPED AND BEFORE THE STRIPE DETECT OCCURRED. IN THE FIRST OCCURRENCE, THE USER DROVE FOR APPROXIMATELY 45 SECONDS WITHOUT THE VISION PROBE BEING FULLY SEATED. IN THE SECOND OCCURRENCE, THE USER DROVE FOR APPROXIMATELY 1.5 MINUTES WITHOUT THE VISION PROBE BEING FULLY SEATED. BECAUSE THE VISION PROBE WAS RE-INSERTED INTO A DIFFERENT ORIENTATION WITHIN THE CATHETER THAT WAS 90 DEGREES OFF FROM THE PREVIOUS CONFIGURATION FOR BOTH OCCURRENCES, THE MOTION COMMANDED WAS UNINTUITIVE UNTIL THE VISION PROBE WAS DETECTED AS BEING FULLY SEATED AND THE ALGORITHM WAS TRIGGERED TO THEN REFLECT THE UPDATED ORIENTATION. STRIPE DETECT OUTPUTTED THE CORRECT ORIENTATION WHEN IT WAS TRIGGERED. PER USER MANUAL 553990: "WHEN INSERTING THE VISION PROBE THROUGH THE CATHETER, THE SYSTEM WILL DETECT THE COLOR STRIPES INSIDE THE CATHETER TO ENSURE VISION IS ORIENTED CORRECTLY WHILE DRIVING. IF THE STRIPES ARE NOT VISIBLE, A MESSAGE APPEARS WHEN THE VISION PROBE REACHES THE CATHETER TIP. THE MESSAGE INDICATES THAT ORIENTATION WAS NOT ACCURATELY DETECTED AND INSTRUCTS USER TO PARTIALLY RETRACT THE VISION PROBE UNTIL THE STRIPES INSIDE THE CATHETER ARE CLEARLY VISIBLE, AND THEN REINSERT THE VISION PROBE THROUGH THE CATHETER. ALWAYS MAKE SURE THE VISION PROBE TIP IS CLEAN. IF THE SYSTEM DOES NOT PRESENT THE MESSAGE BECAUSE IT DID NOT DETECT THE STRIPES (OR IF IT DETECTS THE STRIPES INCORRECTLY), THE VISION PROBE IMAGE WILL APPEAR TO BE 90 OR 180 DEGREES ROTATED, AND DRIVING WILL BE NON-INTUITIVE. IN THIS CASE, PARTIALLY RETRACT THE VISION PROBE UNTIL THE STRIPES INSIDE THE CATHETER ARE CLEARLY VISIBLE, AND THEN REINSERT THE VISION PROBE THROUGH THE CATHETER." NOTE THAT LOG DATA CANNOT BE USED TO CONFIRM THE OCCURRENCE OR CAUSE OF A PNEUMOTHORAX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE LESION WAS 10MM IN SIZE AND LOCATED IN THE APEX OF THE LEFT UPPER LOBE 10MM FROM THE PLEURA. DURING THE PROCEDURE, NAVIGATION WAS COMPLETED AS NORMAL. THE VISION PROBE WAS THEN REMOVED, AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS) WAS PUT DOWN THE TOOL CHANNEL TO CONFIRM THE LESION¿S LOCATION; HOWEVER, WHEN THE VISION PROBE WAS REINSERTED, PER THE PHYSICIAN, THE "LINES" SEEMED TO REGISTER INCORRECTLY, THE ORIENTATION WAS OFF, AND THE ARTICULATION WAS BACKWARDS. THERE WAS ALSO A SIGNIFICANT AMOUNT OF ROTATION/TORQUE WHERE THE PHYSICIAN HAD TO ADJUST THE ROTATION OF THE VIRTUAL IMAGE TO MATCH THE LIVE IMAGE. THE CATHETER WAS RETRACTED FOR A SECOND ATTEMPT AT NAVIGATION, AND THE PHYSICIAN RESTARTED THE NAVIGATION WITHOUT REREGISTRATION. ARTICULATION AGAIN SEEMED NORMAL DURING NAVIGATION, THE VISION PROBE WAS REMOVED AND RADIAL EBUS CONFIRMATION WAS PERFORMED ONCE AGAIN. THE VISION PROBE WAS REINSERTED, BUT THEN ISSUES WITH ARTICULATION FOLLOWING THE TRACKBALL OCCURRED AS BEFORE. THE PHYSICIAN HAD ISSUES WITH MAKING MICRO ADJUSTMENTS, E.G., WHEN ATTEMPTING TO MOVE THE TRACK BALL UP, THE CATHETER WOULD GO DOWN. DURING THE TIME THAT THE ORIENTATION WAS OFF, THE CATHETER TORE THROUGH THE AIRWAY INTO THE LUNG PARENCHYMA. NO LOG ERRORS OCCURRED. THE PHYSICIAN WAS ABLE TO PERFORM BIOPSIES AND COMPLETE THE PROCEDURE. IN POST-PROCEDURE RECOVERY THE PATIENT WAS NOT HYPOXIC, BUT A CHEST X-RAY IDENTIFIED A MODERATE SIZE PNEUMOTHORAX; THEREFORE, A CHEST TUBE WAS PLACED. THE PHYSICIAN BELIEVED THE ION SYSTEM CAUSED THE PNEUMOTHORAX. THE DIAGNOSIS WAS HIGH GRADE NEUROENDOCRINE CARCINOMA. THE PATIENT WAS HOSPITALIZED 2-3 DAYS THEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162629 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male ION ENDOLUMINAL SYSTEM