{ "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": "3014447948-2019-00013", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20191017", "manufacturer_address_2": "", "pma_pmn_number": "K173760", "date_of_event": "20190919", "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": "997922", "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": "16D20190715", "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": "DC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "9203635", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190919", "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": "162831106", "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 INSERTING THE NEEDLE TOO FAR DURING BIOPSY OF THE FIRST TARGET IN THE RIGHT LOWER LOBE, 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": "162831107", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 9/19/19, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE CASE INVOLVED TWO TARGETS, ONE IN THE RIGHT LOWER LOBE AND ONE IN THE RIGHT UPPER LOBE. THE PHYSICIAN FIRST NAVIGATED THE BRONCHOSCOPE TO THE FIRST TARGET, WHICH WAS IN THE RIGHT LOWER LOBE AND COLLECTED BIOPSIES USING AN OLYMPUS PERRY FLEX NEEDLE AND AURIS BIOPSY FORCEPS. AFTER ACQUIRING THE SAMPLE FROM THE TARGET IN THE RIGHT LOWER LOBE, THE PHYSICIAN THEN PROCEEDED TO NAVIGATE THE BRONCHOSCOPE TO THE TARGET IN THE RIGHT UPPER LOBE. WHILE NAVIGATING IN THE RIGHT UPPER LOBE, THE PHYSICIAN OBSERVED THE PNEUMOTHORAX IN THE APEX OF THE LUNG. ON (B)(6) 2019, FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE PATIENT RECEIVED A CHEST TUBE, RECOVERED FROM THE PNEUMOTHORAX, AND WAS RELEASED TWO DAYS AFTER. BASED ON FOLLOW-UP WITH THE CUSTOMER , THAT THERE WAS NO DEVICE FAILURE." } ], "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": "" } ] }