{
  "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,
      "total": 1
    }
  },
  "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": "",
      "manufacturer_contact_address_1": "5490 GREAT AMERICA PKWY",
      "manufacturer_contact_pcity": "40821615",
      "event_type": "Injury",
      "report_number": "3014447948-2025-00030",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20251106",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K211493",
      "date_of_event": "20230410",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95054",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "4082161590",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "KING",
      "source_type": [
        "Health Professional",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "408",
      "date_added": "20251106",
      "manufacturer_contact_f_name": "APRIL",
      "device_date_of_manufacturer": "20220124",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1844710",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20251106",
          "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": "5490 GREAT AMERICA PKWY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SANTA CLARA",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "95054",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "95054",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "EOQ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "B634MON0000060",
          "udi_public": "+B634MON0000060/16D20220124",
          "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": "NY",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20251210",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "4082",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20251106",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Sepsis",
            "Sepsis"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20251106",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "23488215",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20251022",
      "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": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "384479064",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS FOUND THAT THE PATIENT HAD DEVELOPED BRONCHIECTASIS WHICH HAD NOT APPEARED IN PRE-OPERATIVE SCANS. APPROXIMATELY ONE TO TWO DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED SEPSIS AND WAS ADMITTED TO THE HOSPITAL FOR FOUR DAYS AND TREATED WITH ANTIBIOTICS. THE PATIENT¿S LUNG BIOPSIES WERE FOUND TO BE CANCEROUS, AND A SURGICAL LUNG RESECTION WAS PERFORMED. THE LUNG RESECTION ALSO REMOVED THE BRONCHIECTASIS."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "95054",
      "manufacturer_contact_exchange": "408",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}