BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 19579547 · Received June 20, 2024

    Report

    Report Number
    2955842-2024-16064
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PNEUMOTHORAX CANNOT BE DETERMINED. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW.

    Additional Manufacturer Narrative · 0

    ON 08-JUL-2024, THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS RECEIVED: THE TARGET NODULE WAS LOCATED IN THE RIGHT UPPER LOBE APICAL SEGMENT. A RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS UTILIZED TO LOCALIZE THE LESION. BIOPSY TOOLS UTILIZED UNDER C-ARM FLUOROSCOPY INCLUDED A 21G FLEXISION NEEDLE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. A REVIEW OF THE AVAILABLE SYSTEM LOGS WITH THE EVENT DATE OF (B)(6) 2024 DID NOT FIND ANY ERRORS THAT ARE RELEVANT TO THE REPORTED EVENT. INSERTION MOTION REQUIRES BOTH CAPACITIVE TOUCH SENSING (¿CAPTOUCH¿) TO BE ACTIVATED (BY A CONDUCTIVE OBJECT LIKE A FINGER) AND THE MOTION OF THE MOTION CONTROL CONSOLE (MCC) SCROLL WHEEL. CATHETER ARTICULATION REQUIRES MOTION OF THE MCC TRACKBALL. STATE LOGS SHOW THAT CAPTOUCH WAS ACTIVATED MULTIPLE TIMES AND SCROLL WHEEL FORWARD MOTION WAS DETECTED DURING CAPTOUCH ACTIVATION, WHICH RESULTED IN COMMANDED FLEXIBLE INSTRUMENT MANIPULATOR (FIM) INSERTION. WHEN CAPTOUCH WAS NOT ACTIVE ON THE SCROLL WHEEL, THE SCROLL WHEEL COMMANDED INSERTION AND THE ACTUAL INSERTION POSITION STAYED THE SAME. ADDITIONALLY, STATE LOGS SHOW THAT TRACKBALL MOTION WAS DETECTED, WHICH RESULTED IN COMMANDED CATHETER ARTICULATION. THE STATE LOGS SHOW THAT THE ACTUAL INSERTION POSITION TRACKED WITH THE COMMANDED INSERTION POSITION AND THAT ACTUAL ARTICULATION TRACKED WITH COMMANDED ARTICULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT AND 2 DAYS OF HOSPITALIZATION. THE TARGET NODULE WAS 8.7 MILLIMETERS IN SIZE AND LOCATED IN THE RIGHT UPPER LOBE 1 CENTIMETER AWAY FROM THE PLEURA. THE PNEUMOTHORAX WAS IDENTIFIED MID-PROCEDURE VIA COMPUTED TOMOGRAPHY (CT) SCAN, AND A CHEST TUBE WAS PLACED TO RESOLVE IT. THE PROCEDURE WAS COMPLETED AS PLANNED. THE PHYSICIAN REPORTED HAVING TROUBLE WITH THE NAVIGATION; HOWEVER, THE PHYSICIAN CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT. THE PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY DUE PATIENT¿S UNDERLYING CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND EMPHYSEMA.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578009 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES