{
  "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": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MRS.",
      "manufacturer_contact_state": "CA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "REDWOOD CITY",
      "manufacturer_contact_address_1": "150 SHORELINE DRIVE",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "3014447948-2021-00030",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20211222",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K193534",
      "date_of_event": "20211201",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "94065",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "PATEL",
      "source_type": [
        "Health Professional",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "94065",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20211223",
      "manufacturer_contact_f_name": "MONIKA",
      "device_date_of_manufacturer": "20210726",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1956927",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20211222",
          "brand_name": "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": "",
          "model_number": "MON-000006",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "EOQ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "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": "NJ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250821",
      "health_professional": "Y",
      "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": "20211222",
          "sequence_number_treatment": [
            "MONARCH BRONCHOSCOPE",
            " MONARCH FORCEPS",
            " OLYMPUS PERIVIEW FLEX"
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Pneumothorax",
            "Pneumothorax"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20211202",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "REDWOOD CITY",
      "mdr_report_key": "13066562",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20211202",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "94065",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "AURIS HEALTH, INC.",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "285617373",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED DURING POST-PROCEDURE CHEST X-RAY. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED FOUR DAYS AFTER THE PLACEMENT AND THE PATIENT WAS DISCHARGED."
        },
        {
          "mdr_text_key": "285617374",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. THE RISK OF PNEUMOTHORAX IS DOCUMENTED IN 105-000299-01, REV E, 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."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "150 SHORELINE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "94065",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}