BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION SYSTEM

    MDR report key: 23597438 · Received November 19, 2025

    Report

    Report Number
    2955842-2025-45005
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    August 18, 2022
    Report Date
    November 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR ION SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY ION PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY ION PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: LEE-MATEUS, A. Y., REISENAUER, J, GARCIA-SAUCEDO, J. C., ABIA-TRUJILLO, D., BUCKARMA, E. H., EDELL, E. S., GRAGE, R. A., BOWMAN, A. W., LABARCA, G., JOHNSON, M. M., PATEL, N. M., & FERNANDEZ-BUSSY, S. (2022). ROBOTIC-ASSISTED BRONCHOSCOPY VERSUS CT-GUIDED TRANSTHORACIC BIOPSY FOR DIAGNOSIS OF PULMONARY NODULES. RESPIROLOGY, 28(1), 66-73. HTTPS://DOI.ORG/10.1111/RESP.14368.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE, "ROBOTIC-ASSISTED BRONCHOSCOPY VERSUS CT-GUIDED TRANSTHORACIC BIOPSY FOR DIAGNOSIS OF PULMONARY NODULES" WAS PERFORMED. A TOTAL OF 225 PATIENTS WERE INCLUDED - 113 IN THE ROBOTIC-ASSISTED BRONCHOSCOPY (RAB) GROUP AND 112 IN THE COMPUTED TOMOGRAPHY (CT)-GUIDED TRANSTHORACIC BIOPSY (CTTB) GROUP BETWEEN JANUARY 2019 AND MARCH 2021. RAB WAS PERFORMED UNDER GENERAL ANESTHESIA UTILIZING THE ION ENDOLUMINAL SYSTEM USING FLEXIBLE BIOPSY NEEDLES (FLEXISION NEEDLE WITH SIZES RANGING FROM 19 GAUGE TO 23 GAUGE), AND OTHER CONVENTIONAL BIOPSY TOOLS. RAPID ONSITE EVALUATION (ROSE) WAS AVAILABLE IN ALL PROCEDURES TO ASSESS SAMPLE ADEQUACY. COMPLETE MEDIASTINAL AND HILAR STAGING WAS PERFORMED AFTER RAB SAMPLING WAS CONCLUDED. POST-PROCEDURE, ALL PATIENTS RECEIVED CHEST RADIOGRAPHY WITHIN 2 AND 4 HOURS AFTER BRONCHOSCOPY TO EVALUATE FOR PNEUMOTHORAX. PATIENTS RECOVERED AND WERE DEEMED SUITABLE FOR DISCHARGE FOLLOWING EACH CENTER'S PROTOCOLS. RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS) WAS THEN INTRODUCED TO CONFIRM TARGET LOCALIZATION. THE ARTICLE NOTED THAT DURING THESE ION BIOPSY PROCEDURES, PNEUMOTHORAXES OCCURRED IN 4 PATIENTS, REQUIRING ADMISSION FOR OBSERVATION OR CHEST TUBE INSERTION. ONE CASE OF MODERATE HEMOPTYSIS WAS REPORTED, WHICH OCCURRED 4 DAYS POST-PROCEDURE AND WAS ASSOCIATED WITH THE USE OF ANTICOAGULANTS. PER THE AUTHORS, THERE WERE NO ION DEVICE MALFUNCTIONS AND NO ION SYSTEM PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. IT WAS CONCLUDED BY THE AUTHORS THAT RAB, WHEN AVAILABLE, CAN BE AS ACCURATE AS CTTB FOR SAMPLING PULMONARY NODULES WITH SIMILAR OR REDUCED COMPLICATIONS AND SHOULD BE CONSIDERED AS A MEANS FOR NODULE BIOPSY, IN PARTICULAR WHEN MEDIASTINAL STAGING IS ALSO CLINICALLY WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311155 ION SYSTEM ION SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H ION ENDOLUMINAL SYSTEM