BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 18997229 · Received March 28, 2024

    Report

    Report Number
    2955842-2024-12597
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 23, 2024
    Report Date
    February 29, 2024
    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
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S MEDICAL HISTORY IS PROVIDED; PLEASE REFER TO FIELD B7.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER CONCLUDED THAT THE REPORTED PNEUMOTHORAX IS A KNOWN AND EXPECTED COMPLICATION OF BRONCHOSCOPIC LUNG BIOPSIES AND THUS IS PROCEDURE RELATED. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES AND THE EVENT IS NOT DEVICE RELATED. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW OVERALL COMPLICATION RATE. ONE PROSPECTIVE MULTICENTER REGISTRY STUDY OF BRONCHOSCOPIC BIOPSIES OF PERIPHERAL LUNG LESIONS REPORTED 10 PNEUMOTHORACES IN 581 CASES REFLECTING A RATE OF 1.7%. ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF NAVIGATIONAL BRONCHOSCOPY IN 1,215 SUBJECTS REPORTED A TOTAL PNEUMOTHORAX RATE OF 4.3% AND A RATE OF 2.9% REQUIRING HOSPITALIZATION OR INTERVENTION. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED A PNEUMOTHORAX RATE OF 2.5%. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED A PNEUMOTHORAX RATE OF 3.1% WITH A TOTAL OF 7 (1.7%) PATIENTS REQUIRING A CHEST TUBE. OST DE, ERNST A, LEI X, ET AL. DIAGNOSTIC YIELD AND COMPLICATIONS OF BRONCHOSCOPY FOR PERIPHERAL LUNG LESIONS. RESULTS OF THE AQUIRE REGISTRY. AM J RESPIR CRIT CARE MED. 2016;193(1):68-77. FOLCH EE, PRITCHETT MA, NEAD MA, ET AL. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR PERIPHERAL PULMONARY LESIONS: ONE-YEAR RESULTS OF THE PROSPECTIVE, MULTICENTER NAVIGATE STUDY. JOURNAL OF THORACIC ONCOLOGY. 2019. KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. BROWNLEE AR, WATSON JJJ, AKHMEROV A, ET AL. ROBOTIC NAVIGATIONAL BRONCHOSCOPY IN A THORACIC SURGICAL PRACTICE: LEVERAGING TECHNOLOGY IN THE MANAGEMENT OF PULMONARY NODULES. JTCVS. 2023.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, WHO WAS ENROLLED IN A CLINICAL STUDY, UNDERWENT AN ION ENDOLUMINAL BIOPSY PROCEDURE ON (B)(6) 2024 FOR A TARGETED LESION IN THE LEFT LOWER LOBE. THE PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-PROCEDURAL COMPLICATIONS NOR ANY DEVICE MALFUNCTION REPORTED. THE PATIENT'S POST-PROCEDURAL CHEST X-RAY SHOWED A SMALL PNEUMOTHORAX. THE PATIENT WAS DISCHARGED HOME THE SAME DAY WITHOUT PRESENTING ANY SYMPTOMS. ON (B)(6) 2024, THE PATIENT REPORTED WORSENING OF SYMPTOMS AND WAS HOSPITALIZED AFTER CHEST X-RAY SHOWED PNEUMOTHORAX SHOWED INCREASED IN SIZE. A 20 FRENCH SMALL-BORE CHEST TUBE WAS PLACED IN AS A MEDICAL INTERVENTION. THE PNEUMOTHORAX WAS REPORTED AS RESOLVED ON (B)(6) 2024 AND THE PATIENT WAS DISCHARGED THE SAME DAY WITH THE DRAIN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492657 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female ION ENDOLUMINAL SYSTEM