{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
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    "last_updated": "2026-09-08",
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      "manufacturer_contact_zip_ext": "",
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          "manufacturer_d_name": "AURIS HEALTH, INC.",
          "manufacturer_d_address_1": "150 SHORELINE DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "REDWOOD CITY",
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          "openfda": {
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
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      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20210507",
          "sequence_number_treatment": [
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11788796",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210407",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "manufacturer_state": "",
      "distributor_address_2": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "249436265",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. THE RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4) REV D, MONARCH BRONCH RISK MANAGEMENT REPORT. BASED ON THE INFORMATION AVAILABLE FOR THIS EVENT, THE ROOT CAUSE IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE DEVICE LABELING."
        },
        {
          "mdr_text_key": "249436266",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: AN INITIAL EXPERIENCE AT A TERTIARY CENTER. AUTHORS: GUSTAVO CUMBO-NACHELI, RONAK CHHAYA, AND JOHN EGAN. CITATION: CHEST ANNUAL MEETING 2019/ WEDNESDAY ELECTRONIC POSTERS 3/ VOLUME 156, ISSUE 4, SUPPLEMENT , A1767, OCTOBER 01, 2019/ DOI.ORG/10.1016/J.CHEST.2019.08.1538. TWO PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. NO DEVICE ISSUES WERE REPORTED."
        }
      ],
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}