{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DRIVE", "manufacturer_contact_pcity": "510605-7", "event_type": "Injury", "report_number": "3014447948-2022-00037", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20221110", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20221014", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "510605-711", "noe_summarized": "1", "manufacturer_contact_l_name": "KAUR", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "510", "date_added": "20221110", "manufacturer_contact_f_name": "HARMINDER", "device_date_of_manufacturer": "20200902", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "483792", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20221110", "brand_name": "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": "HEALTH PROFESSIONAL", "model_number": "MON-000006", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "B634MON0000060", "udi_public": "+B634MON0000060/16D20200902", "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": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/06/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250806", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5106", "patient": [ { "patient_sequence_number": "1", "date_received": "20221110", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Decreased Respiratory Rate", "Decreased Respiratory Rate" ] } ], "distributor_city": "", "date_report": "20221213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15772091", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20221014", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94065", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "303431029", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "303431030", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A MONARCH BRONCHOSCOPY PROCEDURE ON (B)(6) 2022, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022, EXPERIENCING SHORTNESS OF BREATH. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN WHO PERFORMED THE BRONCHOSCOPY DOES NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM, STATING IT WAS A RESULT OF THE NEEDLE BEING DEPLOYED INTO THE EDGE OF THE PLEURA. THE PATIENT DID NOT EXPERIENCE ANY OTHER ISSUES OTHER THAN SHORTNESS OF BREATH. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022, A X-RAY WAS PERFORMED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO EVIDENCE THAT THE MONARCH SYSTEM DID NOT PERFORM AS INTENDED." }, { "mdr_text_key": "333485732", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR SYSTEM 120011 AND THERE WERE NO NON-CONFORMANCES RELATED TO THE SHORTNESS OF BREATH REPORTED IN THIS CASE. 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. - SELECTED PRODUCT PROBLEM IN ERROR - G07002." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "510", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/13/2022" } ] }