{ "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": "3014447948-2022-00024", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220825", "manufacturer_address_2": "", "pma_pmn_number": "K193534", "date_of_event": "20210617", "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": [ "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "574", "date_added": "20220825", "manufacturer_contact_f_name": "ANDRIA", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2368541", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220825", "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-000005", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "B634MON0000050", "udi_public": "+B634MON0000050/16D20190304", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/14/2022", "mfr_report_type": "Initial", "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": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20220825", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "41 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Chest Pain", "Pneumothorax", "Chest Pain", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20220914", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15298112", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190304", "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": "298663006", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS EVENT WAS REPORTED FROM THE TRANSBRONCHIAL BIOPSY ASSISTED BY ROBOT GUIDANCE IN THE EVALUATION OF TUMORS OF THE LUNG (TARGET) STUDY 19-BR-0001 (NCT04182815). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. RISK OF PNEUMOTHORAX IS DOCUMENTED IN 105-000299-01, REV F, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. 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. SERIAL NUMBER: (B)(4)." }, { "mdr_text_key": "298663007", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF LUPUS AND A RECENT BRONCHOSCOPY FOR A BIOPSY OF THE LEFT LUNG NODULE RETURNED TO THE HOSPITAL THE FOLLOWING MORNING FOR PAIN IN THE LEFT CHEST AND REQUESTED A CHEST X-RAY FOR FURTHER EVALUATION. THE PATIENT DENIES SHORTNESS OF BREATH BUT REPORTS INCREASED PAIN WITH DEEP BREATHING. THE PATIENT DID HAVE A POST PROCEDURE X-RAY DONE FOLLOWING THE PROCEDURE WHICH SHOWED NO PNEUMOTHORAX. THE PATIENTS PAIN STARTED ON THE WAY HOME FROM THE PROCEDURE THE PREVIOUS DAY. A THORA VENT WAS PLACED INTO THE LEFT CHEST. SUCTIONING WAS USED FOR ABOUT AN HOUR. A REPEAT X-RAY AT THAT TIME SHOWED NEAR COMPLETE RESOLUTION OF THE PNEUMOTHORAX ON THE LEFT. THE PATIENT CONTINUED TO FEEL WELL AND WAS NOT HOSPITALIZED. THE PATIENT RETURNED THE FOLLOWING DAY TO HAVE THE THORA VENT REMOVED AND REPORTED TOLERATED THE DEVICE WELL, NO SHORTNESS OF BREATH AS WELL AS NO SIGNIFICANT LEFT CHEST PAIN." }, { "mdr_text_key": "331693945", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOW-UP REPORT IS BE SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: THERE WERE NO DEVICE MALFUNCTIONS REPORTED FROM THE PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR SYSTEM 110024 AND THERE WERE NO NON-CONFORMANCES RELATED TO THE PNEUMOTHORAX 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. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH REGULAR COMPLAINT TREND REVIEW. THE FOLLOW-UP REPORT IS BE SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, G4 G3: 09/12/2022. G4: K173760." } ], "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": "09/14/2022" } ] }