BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24364704 · Received February 17, 2026

    Report

    Report Number
    2955842-2026-04119
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 17, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116241
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS ADVERSE EVENT. THERE IS NO INDICATION THAT THE CUSTOMER REPORTED COMPLICATION OF PNEUMOTHORAX WAS RELATED TO A PRODUCT ISSUE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE PROCEDURE. AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A SYSTEM LOG REVIEW WAS NOT PERFORMED, AS THE REPORTED COMPLAINT IS NOT ASSOCIATED WITH ANY SYSTEM ERRORS OR LOGGED SYSTEM EVENTS. PNEUMOTHORAX IS A COMMON COMPLICATION FOR LUNG BIOPSIES. IT USUALLY REQUIRES AN INTEGRITY BREACH OF THE OUTER LINING OF THE LUNG (E.G., NEEDLE PUNCTURE), WHICH ALLOWS AIR TO ENTER THE PLEURAL SPACE, WHICH MAY LEAD TO A LUNG COLLAPSE. THE PROBABILITY AND RISK FOR PLEURAL PUNCTURE THROUGH THE ENDOLUMINAL ROUTE INCREASES WITH THE LESION¿S PROXIMITY TO THE PLEURA. RISK OF PNEUMOTHORAX IS INCLUDED WITHIN THE RISK MANAGEMENT REPORT FOR THE ION SYSTEM. BASED ON THE INFORMATION, THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK AS DOCUMENTED IN THE LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PNEUMOTHORAX AFTER AN ION BIOPSY PROCEDURE. THE PATIENT REQUIRED CHEST TUBE PLACEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ION SYSTEM DID NOT EXHIBIT ANY ISSUES OR UNEXPECTED BEHAVIORS THAT MAY HAVE CONTRIBUTED TO THE PNEUMOTHORAX. THE LESION BIOPSIED WAS 7MM FROM THE PLEURA, AND MEASURED 9MM. IT WAS LOCATED IN THE RIGHT LOWER LOBE. NO DIAGNOSIS HAS BEEN DETERMINED. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN, AND AN 8FR PIGTAIL CHEST TUBE WAS PLACED. THE PATIENT WAS ALSO PLACED ON OXYGEN. THE PHYSICIAN STATES IT IS UNKNOWN WHAT CAUSED THE PNEUMOTHORAX, WHICH WAS MODERATE IN SIZE, AND INCREASED OVER TIME. IN ADDITION TO MEDICAL TREATMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAS A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND HISTORY OF TOBACCO USE. THE PATIENT REMAINS HOSPITALIZED, PENDING DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430451 ION CONTROLLER EOQ INTUITIVE SURGICAL, INC 380707-55 N/A 00886874116241

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H ION ENDOLUMINAL SYSTEM