BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24958532 · Received April 22, 2026

    Report

    Report Number
    2955842-2026-22485
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    February 10, 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 DID NOT REPORT THAT THE COMPLICATION OF PNEUMOTHORAX WAS RELATED TO A PRODUCT ISSUE, AND 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

    DURING AN ION PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PHYSICIAN REPORTED THAT THE ION SYSTEM DID NOT EXHIBIT ANY ISSUES OR UNEXPECTED BEHAVIOR. THE LESION BIOPSIED WAS 2CM AND LOCATED IN THE LEFT UPPER LUNG. DISTANCE FROM LESION TO PLEURA WAS 5MM. A DIAGNOSIS OF SQUAMOUS CELL CARCINOMA WAS OBTAINED. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND A 14 FR CHEST TUBE WAS PLACED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR GREATER THAN 24 HOURS. AT THE LAST FOLLOW UP THE PATIENT WAS STABLE. MEDICAL HISTORY INCLUDES EMPHYSEMA, HEART FAILURE WITH REDUCED EJECTION FRACTION, CHRONIC RESPIRATORY FAILURE WITH HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017562 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-63 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Hospitalization| R ION ENDOLUMINAL SYSTEM