{
  "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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    {
      "manufacturer_contact_zip_ext": "",
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      "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": "62825447",
      "event_type": "Injury",
      "report_number": "3014447948-2024-00024",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K211493",
      "date_of_event": "20241004",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "94065",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "6282544750",
      "noe_summarized": "1",
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        "Company representation"
      ],
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      "manufacturer_g1_postal_code": "94065",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "628",
      "date_added": "20241031",
      "manufacturer_contact_f_name": "HARMINDER",
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      "previous_use_code": "R",
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        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1961803",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20241031",
          "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",
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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": "+B634MON0000060/16D20210610",
          "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": "US",
      "date_changed": "20250822",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "6282",
      "patient": [
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          "patient_sequence_number": "1",
          "date_received": "20241031",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Pneumothorax",
            "Pneumothorax"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20241031",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "REDWOOD CITY",
      "mdr_report_key": "20582720",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20241004",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "94065",
      "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": "355597816",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "AURIS FAILURE ANALYSIS (FA) ENGINEERING REVIEWED THE COMPLAINT INFORMATION PROVIDED AND UPON REVIEW OF THE COMPLAINT INFORMATION IT WAS CONFIRMED THAT THERE WAS NO ALLEGATION AGAINST THE MONARCH SYSTEM. FURTHER INVESTIGATION OF THE REPORTED ISSUE IS NOT REQUIRED."
        },
        {
          "mdr_text_key": "355597817",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED AFTER THE MONARCH BRONCHOSCOPY CASE WAS COMPLETED SUCCESSFULLY  PATIENT EXPERIENCED A PNEUMOTHORAX SAME DAY.  CHEST TUBE IS BEING EMPLANED TO ADDRESS  PNEUMOTHORAX. PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO MONARCH AND CONSIDERS IT A NORMAL RISK OF A PLURAL TARGET."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "150 SHORELINE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "94065",
      "manufacturer_contact_exchange": "628",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}