{ "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": "3014447948-2018-00002", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181213", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20181113", "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": "20181213", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "998430", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181213", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20181213", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20181213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8163153", "removal_correction_number": "", "number_devices_in_event": "", "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": "130364822", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO AURIS THAT A PNEUMOTHORAX WAS IDENTIFIED IN A PATIENT FOLLOWING A BRONCHOSCOPY PROCEDURE PERFORMED USING THE MONARCH SYSTEM. ACCORDING TO THE REPORT, THE PHYSICIAN USED THE MONARCH TO SUCCESSFULLY BIOPSY A LESION LOCATED PROXIMAL TO A LARGE CAVITY (~3CM IN DIAMETER) AS CONFIRMED BY NAVIGATION, RADIAL ULTRASOUND, AND FLUOROSCOPY. ON THE PHYSICIAN'S SECOND BIOPSY, A POSITIVE DIAGNOSIS WAS REPORTED. THE PHYSICIAN SUBSEQUENTLY OBTAINED A 3RD BIOPSY SAMPLE, WITH A TECHNICIAN ADVANCING THE NEEDLE SHEATH FOR A 4TH SAMPLE. DURING THE 4TH PASS, THE TECHNICIAN INADVERTENTLY EXTENDED THE NEEDLE SHEATH BEYOND THE EXPECTED POSITION. THE DEVICE PERFORMED AS INTENDED. THE DEVICE WAS RETURNED FOR EVALUATION AND IT WAS VERIFIED THAT IT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS." }, { "mdr_text_key": "130364823", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PHYSICIAN REPORTED A PNEUMOTHORAX 2 HOURS POST PROCEDURE AND REQUIRED CHEST TUBE PLACEMENT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND RELEASED UPON THE PNEUMOTHORAX RESOLVING ITSELF WITH NO RESIDUAL EFFECTS." } ], "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": "" } ] }