{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3014447948-2019-00014", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20191017", "manufacturer_address_2": "", "pma_pmn_number": "K173760", "date_of_event": "20190920", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20191017", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "995874", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191017", "brand_name": "MONARCH ENDOSCOPY PLATFORM (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": "I", "model_number": "", "catalog_number": "MON-000005", "lot_number": "16D20190613", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "EOQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20191017", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20190920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9203554", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190920", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "162844412", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO DEVICES WERE RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. IT WAS THE PHYSICIAN'S BELIEF THAT THE PNEUMOTHORAX WAS CAUSED BY BEING AGAINST AN AIRWAY AND THE AIRWAY WAS NOT PUNCTURED WITH ANY INSTRUMENTS,HOWEVER AURIS WAS UNABLE TO CONFIRM. RISK OF PNEUMOTHORAX IS DOCUMENTED IN 105-000198-01, REV E, MONARCH BRONCH RISK MANAGEMENT REPORT .BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING." }, { "mdr_text_key": "162844413", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 9/20/2019, IT WAS REPORTED THAT AFTER A MONARCH- ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS UNKNOWN. THE LESION WAS LOCATED IN THE RIGHT UPPER LOBE. THE PHYSICIAN DROVE TO THE LESION AND COLLECTED A BIOPSY USING A SUPERD ARCPOINT NEEDLE, SUPERD TRIPLE NEEDLE BRUSH AND AURIS FORCEPS. THE PNEUMOTHORAX WAS UNKNOWN UNTIL AFTER THE CASE WAS COMPLETED. ON (B)(6) 2019,FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE PATIENT RECEIVED A CHEST TUBE, THE PATIENT RECOVERED FROM THE PNEUMOTHORAX, AND WAS RELEASED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }