{
  "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": {
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      "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": "",
      "manufacturer_contact_address_1": "5490 GREAT AMERICA PKWY",
      "manufacturer_contact_pcity": "40821615",
      "event_type": "Injury",
      "report_number": "3014447948-2026-00017",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20260413",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K211493",
      "date_of_event": "20260331",
      "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",
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        "Company representation"
      ],
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260413",
      "manufacturer_contact_f_name": "APRIL",
      "device_date_of_manufacturer": "20230619",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20260413",
          "brand_name": "MONARCH ENDOSCOPY 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",
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          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "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": "+B634MON0000060/16D20230619",
          "openfda": {
            "device_name": "Bronchoscope (Flexible Or Rigid)",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.4680",
            "device_class": "2"
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        }
      ],
      "product_problems": [
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      ],
      "reporter_state_code": "MI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260414",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "patient_sequence_number": "1",
          "date_received": "20260413",
          "sequence_number_treatment": [
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            " PERIVIEW FLEX 20G NEEDLE , LO# FE10185 ((OLYMPUS))"
          ],
          "sequence_number_outcome": [
            "Hospitalization"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Aortic dissection"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260413",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "24867158",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260331",
      "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": "398298628",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE TEAM STRUCK THE PATIENT'S AORTA WHILE PERFORMING A BIOPSY WITH AN OLYMPUS PREVIEW NEEDLE. COLD SALINE WAS INJECTED AND THE CASE WAS ABORTED. THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY, (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "95054",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}