{
  "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/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-08",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3014447948-2019-00018",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20191122",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K173760",
      "date_of_event": "20191029",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NURSE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "COMPANY REPRESENTATIVE",
        "HEALTH"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20191122",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1157899",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20191122",
          "brand_name": "MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)",
          "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES",
          "manufacturer_d_name": "AURIS HEALTH, INC.",
          "manufacturer_d_address_1": "150 SHORELINE DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "REDWOOD CITY",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "94065",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "94065",
          "device_operator": "I",
          "model_number": "MON-000005",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "EOQ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Bronchoscope (Flexible Or Rigid)",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.4680",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem",
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250824",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20191122",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Pneumothorax",
            "Pneumothorax"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20191029",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "9360470",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20191029",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "168448861",
          "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 105-000198-01, REV E, MONARCH BRONCH RISK MANAGEMENT REPORT. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE DEVICE LABELING."
        },
        {
          "mdr_text_key": "168448862",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2019, THE CUSTOMER REPORTED THAT A PATIENT HAD A PNEUMOTHORAX. THE PNEUMOTHORAX WAS FOUND AND REPORTED AFTER THE PROCEDURE WHILE THE PATIENT WAS IN POST ANESTHESIA CARE FOLLOW-UP. THE PLAN HAD TWO TARGETS, ONE IN RIGHT UPPER LUNG (RUL) AND ONE IN LEFT LOWER LUNG (LLL). THE LOCATION OF THE PNEUMOTHORAX WAS IN THE RUL. THE PHYSICIAN USED AN AURIS CYTOLOGY BRUSH, AN AURIS BIOPSY FORCEPS, AND A COOK EUS 22GAUGE NEEDLE (AKA ECHO TIP). AT THIS TIME, THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX WAS CAUSED BY ANY AURIS INSTRUMENT OR DEVICE. A FOLLOW-UP WITH THE ACCOUNT MANAGER FOR THE SITE CONFIRMED THAT A CHEST TUBE WAS PLACED IN THE PATIENT WHO RECOVERED AND WAS RELEASED ON THE FOLLOWING DAY. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO DEVICE FAILURE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}