{ "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": "65020852", "event_type": "Injury", "report_number": "3014447948-2023-00006", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20230223", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230124", "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": "6502085208", "noe_summarized": "1", "manufacturer_contact_l_name": "NACHBAR", "source_type": [ "Foreign", "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "CA", "manufacturer_contact_area_code": "650", "date_added": "20230223", "manufacturer_contact_f_name": "MONICA", "device_date_of_manufacturer": "20220808", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "514964", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230223", "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": "B634MON0000060", "udi_public": "+B634MON0000060/16D20220808", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/24/2023;03/24/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250728", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6502", "patient": [ { "patient_sequence_number": "1", "date_received": "20230223", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "57 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Dyspnea", "Hemoptysis", "Pneumothorax", "Dyspnea", "Hemoptysis", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20230325", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "16432676", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230125", "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": "334740303", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO ALLEGED DEVICE MALFUNCTION REPORTED FROM THE PROCEDURE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE MONARCH PLATFORM AND THERE WERE NO NON- CONFORMANCES RELATED TO THE REPORTED INCIDENT. ENGINEERING WAS UNABLE TO EVALUATE THE SYSTEM LOGS OR THE MEDICAL DEVICE. NO FURTHER INVESTIGATION IS REQUIRED AS THERE IS INDICATION THAT THE REPORTED EVENT WAS DUE TO A DEVICE MALFUNCTION AND ALSO IT HAS BEEN STATED THAT THERE ARE NO ALLEGATIONS TOWARDS THE MONARCH PLATFORM." }, { "mdr_text_key": "310148527", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PATIENT WAS ADMITTED FOR IN-PATIENT HOSPITALIZATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED. THE PATIENT WAS RELEASED TWO (2) DAYS LATER. THE HOSPITAL CLINICAL RESEARCH COORDINATOR REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. AFTER THE PROCEDURE, THE PATIENT REPORTED HAEMOPTYSIS. THE PATIENT¿S HAEMOPTYSIS WAS REPORTED AS POSSIBLY RELATED TO USE OF THE MONARCH SYSTEM. THE PATIENT¿S SYMPTOM WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP TO THE BRONCHOSCOPY PROCEDURE. THE HAEMOPTYSIS WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. IN ADDITION, THE PATIENT REPORTED SHORTNESS OF BREATH. THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS NOT RELATED TO USE OF THE MONARCH SYSTEM. HOWEVER, THE PATIENT¿S SYMPTOM WAS REPORTED AS POSSIBLY RELATED TO THE BRONCHOSCOPY PROCEDURE. ON FEBRUARY 17, 2023, THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. THERE WAS NO REPORTED MALFUNCTION OF THE MONARCH BRONCHOSCOPY SYSTEM." } ], "number_patients_in_event": "", "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": "03/24/2023;03/25/2023" } ] }