{
  "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",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MRS.",
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          "device_report_product_code": "EOQ",
          "device_age_text": "",
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          "udi_public": "",
          "openfda": {
            "device_name": "Bronchoscope (Flexible Or Rigid)",
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        "Use of Device Problem"
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      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250808",
      "health_professional": "Y",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
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      "date_report": "20230922",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "REDWOOD CITY",
      "mdr_report_key": "17802996",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20230824",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "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": "324106383",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE, A RECURRENT ELECTROMAGNETIC (EM) NAVIGATION FAULT OCCURRED AT SYSTEM REGISTRATION.  THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE.  NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT."
        },
        {
          "mdr_text_key": "324106384",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "USER FAILED TO FOLLOW THE PROVIDED INSTRUCTIONS FOR USE.  CONTRAINDICATIONS INCLUDE USE OF THE SYSTEM IN PATIENTS WITH ELECTRICALLY OR MAGNETICALLY ACTIVATED IMPLANTED MEDICAL DEVICES."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "150 SHORELINE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "94065",
      "manufacturer_contact_exchange": "650",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}