{ "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": "", "event_type": "Injury", "report_number": "3014447948-2022-00008", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220615", "manufacturer_address_2": "", "pma_pmn_number": "K193534", "date_of_event": "20220419", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "SMITH", "source_type": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20220615", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20210922", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1657961", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220615", "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": "ASMITH6@ITS.JNJ.COM", "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": "B634MON000005010", "udi_public": "+B634MON000005010/16D20210922", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/20/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250803", "health_professional": "Y", "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": "20220615", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "14700731", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220520", "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": "294911639", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE DUE TO CONCERNS FOR POTENTIAL PNEUMOTHORAX (HIGH PEAK PRESSURE AND DECLINING 02 SATURATIONS). THE PHYSICIAN OBTAINED A PORTABLE CHEST X-RAY (CXR) AND A LEFT SIDED PNEUMOTHORAX WAS NOTED. THE PHYSICIAN PROCEEDED TO PLACE A 14G WAYNE PNEUMOTHORAX CHEST TUBE AT THE BEDSIDE. THE PATIENT WAS ADMITTED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY." }, { "mdr_text_key": "294911640", "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 (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4), 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." }, { "mdr_text_key": "331297232", "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 7/18/2022. DUE TO THE ABSENCE OF LOGS, A FULL FAILURE ANALYSIS CANNOT BE PERFORMED AGAINST THE SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO REPORTS OF NONCONFORMANCE THAT RELATE TO THE REPORTED INCIDENT. A REVIEW FOR SIMILAR COMPLAINT SHOWS THE REPORTED ISSUE IS A KNOWN ISSUE HOWEVER THE ROOT CAUSE IS SPECIFIC TO EACH INDIVIDUAL CASE. RISK OF PNEUMOTHORAX IS DOCUMENTED IN 105-000299-01, REV F, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. THIS ISSUE WILL BE TRACKED AND TRENDED IN THE MONTHLY COMPLAINT TREND REVIEW MEETINGS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/18/2022" } ] }