BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24958725 · Received April 22, 2026

    Report

    Report Number
    2955842-2026-22487
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 22, 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
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE COMPLICATION OF PNEUMOTHORAX WAS NOT RELATED TO A PRODUCT ISSUE. THE ION SYSTEM DID NOT EXHIBIT ANY ISSUES OR UNEXPECTED BEHAVIOR. AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED A PNEUMOTHORAX DURING AN ION PROCEDURE. PER THE PHYSICIAN, THE ION SYSTEM DID NOT EXHIBIT ANY ISSUES OR UNEXPECTED BEHAVIOR. THE LESION BIOPSIED WAS 4.5CM AND WAS LOCATED IN THE RIGHT UPPER LUNG. THE DISTANCE FROM THE LESION TO THE PLEURA WAS 23MM. A DIAGNOSIS OF ADENOCARCINOMA WAS OBTAINED. THE LIKELY CAUSE OF THE PNEUMOTHORAX IS EMPHYSEMA. THE PNEUMOTHORAX MEASURED 14MM, AND DID NOT INCREASE IN SIZE. A 14FR CHEST TUBE WAS PLACED. PATIENT SYMPTOMS WERE NOT REPORTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND REMAINED FOR 7 DAYS, WITH LAST FOLLOW UP REPORTED AS STABLE. NO OTHER MEDICAL HISTORY WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017848 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-63 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R ION ENDOLUMINAL SYSTEM