{
  "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": "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": "3014447948-2024-00001",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20240229",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K211493",
      "date_of_event": "20240208",
      "reprocessed_and_reused_flag": "Y",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "94065",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "6282544750",
      "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": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "628",
      "date_added": "20240229",
      "manufacturer_contact_f_name": "HARMINDER",
      "device_date_of_manufacturer": "20210726",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2196675",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20240229",
          "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": "",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Bronchoscope (Flexible Or Rigid)",
            "medical_specialty_description": "Ear, Nose, Throat",
            "regulation_number": "874.4680",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Failure to Align",
        "Failure to Align"
      ],
      "reporter_state_code": "NJ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250817",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "6282",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20240229",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20240229",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "REDWOOD CITY",
      "mdr_report_key": "18810177",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240227",
      "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": "336585451",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "UPON LOGS REVIEW IT WAS CONFIRMED THAT THE CASE REQUIRED SIGNIFICANT ARTICULATION OF THE BRONCHOSCOPE TO NAVIGATE A SHARP TURN AND REACH THE TARGET. THE ARMS WERE ADDING MORE FORCES ON THE ROLL JOINT WHICH THE ROLL JOINT MOTOR WAS TRYING TO KEEP UP ITS POSITION. THE EXCESSIVE FORCE WAS APPLIED TO ARM 2 THAT CAUSED THE ARM TO CHANGE POSITION AND THE ARMS TO BECOME MISALIGNED. THE FIELD SERVICE ENGINEER CONDUCTED A PHYSICAL INVESTIGATION AND DID NOT FIND ANY ISSUES WITH THE PERFORMANCE OF THE ARMS."
        },
        {
          "mdr_text_key": "336585452",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE DRIVING THROUGH THE BRONCHIAL ANATOMY TO THE TARGET LOCATION IN THE RIGHT UPPER LOBE (RUL). THE PATIENT ANATOMY REQUIRED THE BRONCHOSCOPE TO MANEUVER THROUGH A DIFFICULT/TIGHT SHARP TURN. THE MONARCH SYSTEM PRODUCED MULTIPLE FAULT CODES. THE PHYSICIAN WAS NOT ABLE TO REACH THE TARGET AND ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES."
        }
      ],
      "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": ""
    }
  ]
}