{ "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": "3014447948-2019-00016", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20191107", "manufacturer_address_2": "", "pma_pmn_number": "K173760", "date_of_event": "20191010", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "501", "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": "20191107", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1086856", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191107", "brand_name": "MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)", "generic_name": "BRONCHOSCOPE (FLEXIBLE 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": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "MON-000005", "lot_number": "16D20190221", "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": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20191107", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Infarction", "Pulmonary Infarction" ] } ], "distributor_city": "", "date_report": "20191010", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9293770", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20191010", "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": "166946237", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO DEVICES WERE RETURNED FOR EVALUATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION, THERE WERE NO AURIS DEVICE MALFUNCTIONS THAT COULD HAVE CONTRIBUTED TO THE OCCURRENCE OF THE PNEUMOTHORAX. IT WAS THE PHYSICIAN'S BELIEF THAT THE PNEUMOTHORAX WAS CAUSED BY PATIENT'S POOR LUNG TISSUE STATE. 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": "166946238", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 10/10/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET WAS IN LEFT UPPER LOBE (LUL) APICAL POSTERIOR SEGMENT NEAR THE PLEURA. THE INSTRUMENTS USED WERE AURIS BRONCHOSCOPE, REBUS PROBE AND SUPERD ARC POINT NEEDLE. THE PHYSICIAN TOOK BIOPSIES USING SUPERD ARC POINT NEEDLE. IT WAS REPORTED THAT AFTER SUCCESSFUL FIRST AND SECOND PASSES, THE PHYSICIAN OBSERVED PNEUMOTHORAX ON THE THIRD PASS. AFTER COMPLETING THE PROCEDURE, A CHEST TUBE WAS PLACED IN THE PATIENT. THE CUSTOMER CONFIRMED ON (B)(6) 2019 THAT PNEUMOTHORAX WAS RESOLVED AFTER CHEST TUBE PLACEMENT AND THE PATIENT WAS DISCHARGED." } ], "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": "" } ] }