{ "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": "3014447948-2019-00015", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20191017", "manufacturer_address_2": "", "pma_pmn_number": "K173760", "date_of_event": "20190923", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "995315", "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, PRODUCT CODE: EOQ", "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": "", "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": "B634MON0000050", "udi_public": "+B634MON0000050/16D20181106", "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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20190923", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9203529", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190923", "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": "162844197", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. IT WAS THE PHYSICIAN'S BELIEF THAT THE PNEUMOTHORAX OCCURRED DURING THE BIOPSY WITH EITHER OF THE TWO NON-AURIS INSTRUMENTS USED WHICH WAS NOT CONFIRMED. THE 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 DEVICE LABELING." }, { "mdr_text_key": "162844198", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 9/23/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS NOTED TO BE IN THE SAME AREA AS THE TARGET LESION. THE CUSTOMER CONFIRMED THAT THE CUSTOMER RECEIVED A CHEST TUBE AND SHORTLY RECOVERED AND WAS RELEASED. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO DEVICE FAILURE. 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