BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24673685 · Received March 24, 2026

    Report

    Report Number
    2955842-2026-17300
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 24, 2026
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 BASED ON THE REVIEWED CLINICAL FEEDBACK. AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX AFTER THE ION PROCEDURE. THE PATIENT EXPERIENCED A PNEUMOTHORAX THAT REQUIRED A CHEST TUBE AND HOSPITALIZATION. THE PNEUMOTHORAX OCCURRED DURING THE ION PROCEDURE; THEREFORE, THE PROCEDURE WAS ABORTED. SOME BIOPSIES WERE OBTAINED, BUT NOT GREAT SAMPLES. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ORIGINAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PHYSICIAN STATES THAT THE ION SYSTEM DID NOT EXHIBIT ANY ISSUES OR UNEXPECTED BEHAVIORS THAT MAY HAVE CONTRIBUTED TO THE PNEUMOTHORAX. THE PHYSICIAN REPORTS THAT THE LESION BEING VERY PERIPHERAL IN THE RIGHT MIDDLE LOBE CAUSED THE PNEUMOTHORAX. THE LESION SIZE WAS 1.3CM, LOCATED IN THE RIGHT MIDDLE LUNG, AND 0.5 CM FROM THE PLEURA. NO DIAGNOSIS WAS OBTAINED. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS. TREATMENT PROVIDED WAS PLACEMENT OF A 14FR CHEST TUBE, BREATHING TREATMENTS, AND OXYGEN THERAPY, AS WELL AS ADMISSION TO THE HOSPITAL. THE PATIENT HAS A HISTORY OF TOBACCO ABUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736838 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

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