{ "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": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DRIVE", "manufacturer_contact_pcity": "62825447", "event_type": "Injury", "report_number": "3014447948-2023-00012", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20230421", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230329", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6282544750", "noe_summarized": "1", "manufacturer_contact_l_name": "NACHBAR", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "628", "date_added": "20230421", "manufacturer_contact_f_name": "MONICA", "device_date_of_manufacturer": "20220701", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "807492", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230421", "brand_name": "MONARCH PLATFORM", "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES", "manufacturer_d_name": "AURIS MEDICAL, 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": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/29/2023;06/01/2023;11/16/2023;11/16/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20230421", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20231117", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "16791635", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230329", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94065", "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": "336667906", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE TRACED TO MONARCH AS THERE IS NO ALLEGATION AGAINST THE MONARCH SYSTEM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE MONARCH SYSTEM AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED INCIDENT IN THIS CASE." }, { "mdr_text_key": "336668809", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PHYSICIAN STATED THE MONARCH SYSTEM WAS NOT AT FAULT." }, { "mdr_text_key": "313778748", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2023 IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN FELT A POP WHILE TAKING A BIOPSY WITH A MEDTRONIC ARCPOINT NEEDLE. AFTER COMPLETING THE BIOPSY, THE PHYSICIAN REMOVED THE BRONCHOSCOPE SYSTEM AND THE PATIENT¿S HEART RATE SPIKED TO A REPORTED 190 BPM. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, AND IT WAS DETERMINED THAT NO FURTHER INTERVENTION WAS REQUIRED AT THAT TIME. THE PATIENT WAS TRANSFERRED TO POST ANESTHESIA CARE UNIT (PACU), A CHEST X-RAY WAS PERFORMED, AND A PNEUMOTHORAX WAS CONFIRMED. A CHEST TUBE WAS PLACED, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND RELEASED 3 DAYS LATER." }, { "mdr_text_key": "338934318", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INVESTIGATION IN A FOLLOW UP CALL BETWEEN SENIOR DIRECTOR OF MEDICAL AFFAIRS AND THE PHYSICIAN ON (B)(6) 2023, THE PHYSICIAN CONFIRMED THAT THE PNEUMOTHORAX WAS NOT RELATED TO THE MONARCH SYSTEM. REMOVE H6: D14. CORRECTED DATA G1: MANUFACTURER CONTACT PHONE NUMBER: (B)(6)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "628", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/28/2023;06/01/2023;11/17/2023;11/17/2023" } ] }