BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 14867368 · Received June 30, 2022

    Report

    Report Number
    2955842-2022-12609
    Event Type
    Injury
    Date Received
    June 30, 2022
    Report Date
    March 31, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE AND INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED AS THERE WAS LACK OF PRODUCT AND PROCEDURE INFORMATION. NO ADDITIONAL TECHNICAL REVIEW WAS REQUIRED AND/OR PERFORMED BASED ON THE COMPLAINT SINCE THE EVENT DATE WAS UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN A JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING AN ION SURGICAL PROCEDURE IN WHICH A SIGNIFICANT AMOUNT OF BLEEDING WAS NOTICED: ¿UPON COLLECTING TISSUE SAMPLES WITH A 21-G NEEDLE, BLEEDING WAS NOTED TRAVELING PROXIMALLY ALONG THE ROBOTIC CATHETER AND ON LIVE FLUOROSCOPIC IMAGES (FIG. 2).¿ THE PHYSICIAN INSERTED A FLEXIBLE BRONCHOSCOPE TO ASSIST IN CONTROLLING THE BLEEDING.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ARTICLE TITLED, ¿MANAGEMENT OF SIGNIFICANT AIRWAY BLEEDING DURING ROBOTIC ASSISTED BRONCHOSCOPY: A TAILORED APPROACH¿ (FERNANDEZ-BUSSY, S., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING AN ION SURGICAL PROCEDURE WAS NOTED. THE EXACT EVENT DATE OF THE PROCEDURE WAS NOT NOTED. DURING AN ION PROCEDURE A SIGNIFICANT AMOUNT OF BLEEDING WAS NOTICED: ¿UPON COLLECTING TISSUE SAMPLES WITH A 21-G NEEDLE, BLEEDING WAS NOTED TRAVELING PROXIMALLY ALONG THE ROBOTIC CATHETER AND ON LIVE FLUOROSCOPIC IMAGES (FIG. 2).¿ THE PHYSICIAN INSERTED A FLEXIBLE BRONCHOSCOPE TO ASSIST IN CONTROLLING THE BLEEDING. THE BLEEDING WAS NOTICED COMING FROM THE LEFT UPPER LOBE SURROUNDING THE WEDGED ROBOTICS BRONCHOSCOPE. ICE SALINE AND EPINEPHRINE WERE USED ON THE BRONCHIAL SEGMENT WHERE THE ION CATHETER WAS TO CEASE THE BLEEDING. SUCCESSFUL HEMOSTASIS WAS CONFIRMED, AND SUCTION WAS USED TO REMOVE REMAINING CLOTS. THE ION PROCEDURE WAS CONTINUED AS PLANNED. AFTER THE ION PROCEDURE WAS COMPLETED, SYSTEMATIC MEDIASTINAL STAGING WAS PERFORMED WITH EBUS: NO PNEUMOTHORAX, WORSENING HYPOXEMIA, OR OTHER COMPLICATIONS REPORTEDLY OCCURRED. THE PATIENT WAS DISCHARGED HOME. ON 06-APR-2021, INTUITIVE SURGICAL, INC (ISI) RECEIVED ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE ION PHYSICIAN RESPONDED AND DID NOT PROVIDE THE EXACT DATE OF THIS PROCEDURE. THE PHYSICIAN DOES NOT THINK THE BLEEDING WAS CAUSED BY AN ION PRODUCT. THE BLEEDING WAS CAUSED BY THE NEEDLE BIOPSY PORTION OF THE PROCEDURE. THERE WAS NO ION MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2894022 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female ION ENDOLUMINAL SYSTEM