{ "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": "", "event_type": "Injury", "report_number": "3014447948-2022-00003", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220214", "manufacturer_address_2": "", "pma_pmn_number": "K173760", "date_of_event": "20210525", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "SMITH", "source_type": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20220214", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20190419", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1262946", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220214", "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": "", "model_number": "MON-000005", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "EOQ", "device_age_text": "DA", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/15/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250821", "health_professional": "Y", "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": "20220214", "sequence_number_treatment": [ "MONARCH BRONCHOSCOPE" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "76 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "13525228", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220120", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "287430334", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS EVENT WAS REPORTED FROM THE TRANSBRONCHIAL BIOPSY ASSISTED BY ROBOT GUIDANCE IN THE EVALUATION OF TUMORS OF THE LUNG (TARGET) STUDY 19-BR-0001 ((B)(4)). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4), REV E, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. 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": "287430335", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT DEVELOPED AN IATROGENIC PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). THE PATIENT HAD POSTPROCEDURAL CHEST X-RAYS AT 3:30 P.M. THAT DEMONSTRATED A SMALL APICAL 3-4 MM PNEUMOTHORAX. REPEAT CHEST X-RAY AT 6:30 P.M. SHOWED INCREASED PNEUMOTHORAX TO 1 CM DESPITE BEING ON A FULL-FACE MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND PLACED ON 15 L SALTER CANNULA FOR SUPPORTIVE TREATMENT OF THE PNEUMOTHORAX. OVERNIGHT, THE PATIENT HAD REPEATED X-RAYS WHICH WAS FOUND TO BE STABLE AND THERE WAS NO EVIDENCE OF DESATURATION WITHOUT SUPPLEMENTAL O2. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY." }, { "mdr_text_key": "328008421", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTION H6: B17, D12." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/15/2022" } ] }