{ "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": "3014447948-2019-00003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20190425", "manufacturer_address_2": "", "pma_pmn_number": "K173760", "date_of_event": "20190314", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20190425", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "344630", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190425", "brand_name": "MONARCH PLATFORM", "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID)", "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": "", "catalog_number": "MON-000005", "lot_number": "", "other_id_number": "", "device_availability": "No", "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" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20190425", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Patient Problem/Medical Problem", "Patient Problem/Medical Problem" ] } ], "distributor_city": "", "date_report": "20190422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8547836", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190325", "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": "143078930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE PERFORMED AS INTENDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. PNEUMOTHORAX IS A KNOWN SHORT-TERM COMPLICATION OF BRONCHOSCOPY AND MAY OCCUR WHEN A LUNG BIOPSY IS PERFORMED DURING BRONCHOSCOPY PROCEDURE." }, { "mdr_text_key": "143078931", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT UNDERWENT MONARCH BRONCHOSCOPY PROCEDURE WITH BIOPSY UNDER CLINICAL PROTOCOL AND AURIS BECAME AWARE OF AN EVENT FROM CLINICAL CASE REPORT FORM THAT ON (B)(6) 2019 A PNEUMOTHORAX WAS IDENTIFIED IN A PATIENT FOLLOWING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019 USING THE MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM). ACCORDING TO THE REPORT, A SIX-MILLIMETER PNEUMOTHORAX WAS OBSERVED IN A POST PROCEDURE X-RAY APPROXIMATELY 2 HOURS POST BRONCHOSCOPY PROCEDURE. THE X-RAY WAS REPEATED APPROXIMATELY 3 HOURS POST PROCEDURE AND THE PATIENT WAS DEEMED STABLE AND DISCHARGED FROM THE HOSPITAL. THE PATIENT REPORTED A MILD SORE THROAT AND CHEST PAIN BUT OTHERWISE FELT FINE IN A 24-HOUR FOLLOW-UP PHONE CALL. TWO (2) DAYS AFTER THE PROCEDURE ((B)(6) 2019), AN URGENT CARE PHYSICIAN CONTACTED THE HOSPITAL WHERE THE PROCEDURE WAS PERFORMED TO REPORT THAT AN X-RAY INDICATED A 25% COLLAPSE OF THE PATIENT'S RIGHT LUNG. A FELLOW ADVISED SENDING THE PATIENT TO HOSPITAL TO BE MONITORED WITH REPEAT X-RAY IN MORNING. ON (B)(6) 2019 A FELLOW RECEIVED A CALL FROM PHYSICIAN AT THE HOSPITAL INDICATING THAT THE PATIENT'S PNEUMOTHORAX MEASURED 13 MM AND CHEST CT DEMONSTRATED HYDROPNEUMOTHORAX AT TIME OF ADMISSION. A REPEAT X-RAY DEMONSTRATED 29 MM PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE PATIENT SAW HER NORMAL PULMONOLOGIST ON (B)(6) 2019; AND THE PATIENT WAS FULLY RECOVERED. THE PHYSICIAN WHO PERFORMED THE BRONCHOSCOPY PROCEDURE REPORTED THAT NO MALFUNCTION OF THE AURIS DEVICE WAS OBSERVED AT THE TIME OF THE PATIENT'S PROCEDURE." } ], "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": "" } ] }