{ "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": "MRS.", "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": "57455106", "event_type": "Injury", "report_number": "3014447948-2023-00007", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20230223", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745510671", "noe_summarized": "1", "manufacturer_contact_l_name": "SMITH", "source_type": [ "Foreign", "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "CA", "manufacturer_contact_area_code": "574", "date_added": "20230223", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20220808", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "594620", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230223", "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": "+B634MON0000060/16D20220808", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/24/2023;03/24/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20230223", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "67 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dyspnea", "Hemoptysis", "Pneumothorax", "Dyspnea", "Hemoptysis", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20230325", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "16432767", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94065", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "AURIS HEALTH, INC.", "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": "333696242", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ENGINEERING CONFIRMED THAT THE LOGS OF THE REPORTED EVENT WERE NOT BEING UPLOADED TO THE CLOUD. THREE GOOD FAITH EFFORTS (GFE) WERE MADE ACQUIRING THE LOGS. HOWEVER, THE LOGS HAVE NOT BECOME AVAILABLE AS OF 03/24/2023. DUE TO THE ABSENCE OF LOGS, ENGINEERING IS UNABLE TO CONFIRM THE OCCURRENCE OF THE REPORTED ISSUE. HOWEVER, THERE WERE NO DEVICE MALFUNCTIONS REPORTED FROM THE PROCEDURE. NO FURTHER INVESTIGATION IS REQUIRED AS THERE IS INDICATION THAT THE REPORTED EVENT WAS NOT DUE TO DEVICE MALFUNCTION AND ALSO IT HAS BEEN STATED THAT THERE ARE NO ALLEGATIONS TOWARDS THE MONARCH. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SYSTEM 120164 AND THERE WERE NO NON- CONFORMANCES RELATED TO THE REPORTED INCIDENT IN THIS CASE. THIS ISSUE WILL BE TRACKED AND TRENDED IN THE MONTHLY COMPLAINT TREND REVIEW MEETINGS." }, { "mdr_text_key": "310128631", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX, HEMOPTYSIS, AND DYSPNEA. A PIGTAIL (CHEST TUBE) WAS PLACED AND THE PATIENT WAS HOSPITALIZED AND LATER RELEASED. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/24/2023;03/25/2023" } ] }