{
  "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": "MS.",
      "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": "510605-7",
      "event_type": "Injury",
      "report_number": "3014447948-2022-00033",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20220920",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K211493",
      "date_of_event": "20220819",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "94065",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "510605-711",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "KAUR",
      "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": "510",
      "date_added": "20220920",
      "manufacturer_contact_f_name": "HARMINDER",
      "device_date_of_manufacturer": "20220413",
      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2737991",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20220920",
          "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": "HEALTH PROFESSIONAL",
          "model_number": "MON-000006",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "EOQ",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "B634MON0000060",
          "udi_public": "+B634MON0000060/16D20220413",
          "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": "10/13/2022",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250807",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "5106",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20220920",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hemorrhage/Blood Loss/Bleeding",
            "Hypoxia",
            "Hemorrhage/Blood Loss/Bleeding",
            "Hypoxia"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20221018",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "REDWOOD CITY",
      "mdr_report_key": "15457123",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220822",
      "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": "300261258",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING IN THE LEFT LOWER LOBE DURING THE MONARCH BRONCHOSCOPY PROCEDURE. THE BLEEDING WAS CONTROLLED BY EXOCRINE PANCREATIC INSUFFICIENCY (EPI) ADMINISTRATION. THE PATIENT WAS HOSPITALIZED FOR HYPOXIA AND PLACED ON OXYGEN. PRIOR TO THE PROCEDURE THE PATIENT WAS ON OXYGEN AND CURRENTLY ON OXYGEN AT HOME. THE PATIENT WAS RELEASED THE FOLLOWING DAY."
        },
        {
          "mdr_text_key": "300261259",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED."
        },
        {
          "mdr_text_key": "332942204",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THERE WERE NO DEVICE MALFUNCTIONS REPORTED FROM THE PROCEDURE. NO LOG REVIEW WAS PERFORMED AS THIS EVENT IS RELATED TO PROCEDURE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SYSTEM 120137 AND THERE WERE NO NON- CONFORMANCES RELATED TO THE REPORTED INCIDENT IN THIS CASE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "150 SHORELINE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "94065",
      "manufacturer_contact_exchange": "510",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "10/18/2022"
    }
  ]
}