{ "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 DR.", "manufacturer_contact_pcity": "51060571", "event_type": "Injury", "report_number": "3014447948-2022-00031", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220914", "manufacturer_address_2": "", "pma_pmn_number": "K203614", "date_of_event": "20220817", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5106057113", "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": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "510", "date_added": "20220914", "manufacturer_contact_f_name": "HARMINDER", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2609414", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220914", "brand_name": "MONARCH BRONCHOSCOPE", "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES", "manufacturer_d_name": "AURIS HEALTH, INC.", "manufacturer_d_address_1": "150 SHORELINE DR.", "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": "MBR-000211-A", "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": "", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/14/2022", "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": "5106", "patient": [ { "patient_sequence_number": "1", "date_received": "20220914", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20221014", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15421965", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220818", "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": "299902724", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INVESTIGATION IS IN PROCESS." }, { "mdr_text_key": "299902765", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A MONARCH BRONCHOSCOPY DEVELOPED A PNEUMOTHORAX AND WAS VERIFIED VIA CHEST X-RAY. THE TARGET WAS A RML LESION ON THE FISSURE. A CHEST TUBE PLACED, THE PATIENT WAS ADMITTED OVERNIGHT, AND DISCHARGED ON (B)(6) 2022. A MEDTRONIC ARCPOINT NEEDLE AND MONARCH FORCEPS (WHICH WERE DISCARDED) WERE USED DURING THIS CASE. THE PHYSICIAN REPORTED THAT THEY DON'T BELIEVE THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH SYSTEM, BUT RATHER BY THE LOCATION OF THE NODULE IN RELATION TO THE FISSURE. THE CASE WAS COMPLETED SUCCESSFULLY." }, { "mdr_text_key": "332498771", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED B4,G3, G6, H2, H6, H10 SCOPE IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS REPROCESSED AS PER PROCESS AND SERIAL NUMBER IS NOT AVAILABLE. THE REPORTED ISSUE OCCURRED ON A DEVICE USED FOR DIAGNOSIS AND NOT TREATMENT. THERE WERE NO DEVICE MALFUNCTIONS REPORTED FROM THE PROCEDURE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SYSTEM 120115 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 LABELLING. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH REGULAR COMPLAINT TREND REVIEW." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "510", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/14/2022" } ] }