{ "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 DR.", "manufacturer_contact_pcity": "57455106", "event_type": "Injury", "report_number": "3014447948-2023-00008", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230227", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230220", "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": [ "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": "574", "date_added": "20230227", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20200902", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "787156", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230227", "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": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Unintended Movement", "Unintended Movement" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/18/2023;04/18/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "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": "20230227", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20230419", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "16442752", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230220", "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": "334949707", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE USER DRIVES TO A TARGET IN THE LLL (LEFT LOWER LOBE) BUT WHEN THEY RETRACT TO THE TRACHEA, THE USER ARTICULATES STRONGLY TO THE RIGHT WHILE IN THE LMB (LEFT MIDDLE BRONCHUS). THIS CAUSES THE SCOPE TO FLICK INTO THE RMB (RIGHT MIDDLE BRONCHUS), THOUGH THE SCOPE NEVER RETRACTED (FROM A ROBOTIC DEPTH STANDPOINT) INTO THE TRACHEA. THE USER THEN PROCEEDS INTO THE RIGHT LUNG WHILE FUSION STILL SHOWS THEM ON THE LEFT SIDE. THE USER RECEIVES A 1203 FAULT AT THE END OF THE RMB, BUT CLEARS IT AND PROCEEDS INTO THE RLL. FUSION IS STILL SHOWING THEM ON THE LEFT SIDE. ALL TARGETS THAT THE USER PLANNED FOR ARE IN THE LEFT LUNG. THE USER PROCEEDS TO USE TOOLS IN THE RIGHT LUNG, THOUGH THE FUSION POSITION DISPLAYED DOES NOT MATCH THE ANATOMY THE USER IS SEEING IN THE CAMERA VIEW. THE USER DOES NOT APPEAR TO BE USING THE NAVIGATION VIEWS AND THE COMPLAINT DESCRIPTION INDICATES SIMILARLY. MOREOVER, THE AM REPORTED THAT THE USER WAS DRIVING UNDER FLUOROSCOPY DURING THIS PORTION OF THE CASE, BUT STILL PROCEEDED TO DRIVE AND USE TOOLS IN THE RIGHT LUNG. THE TIME OF THE PNEUMOTHORAX EVENT IS NOT CLEAR. A REVIEW OF THE CASE VIDEO CONFIRMED AN EM NAV ERROR, RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. THE FAULT ID: 1200-50-0-0. ¿NAV SCOPE EM QUALITY¿ OCCURRED WHILE THE CUSTOMER WAS TRANSITING TOWARDS THE TARGET LOCATION BETWEEN 41:53-47:00 DURING THE CASE VIDEO. A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCTION FINAL ACCEPTANCE TESTING REVEALED ALL ACCEPTANCE CRITERIA WERE MET AND NO ANOMALIES FOUND. BASED ON THE RESULTS FROM THE EXAMINATION, THE SCOPE PRODUCT MET SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO ALGORITHM LIMITATION." }, { "mdr_text_key": "310233671", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING THE 1ST CASE OF THE DAY (PATIENT IN THE ROOM UNDER ANESTHESIA) PHYSICIAN REPORTED PNEUMOTHORAX. SYSTEM INITIALIZED CORRECTLY, SETUP AND SCOPE REGISTRATION HAD NO ISSUES. WHEN NAVIGATING TO THE TARGET IN LEFT LOWER LOBE, 100MM FROM THE TARGET, THE PHYSICIAN BACKED OUT ALL THE WAY TO MAIN CARINA AND WENT BACK WITHOUT RE-REGISTERING THE SCOPE. THE PHYSICIAN WAS MOVING BACK AND FORTH, WAS FOLLOWING FLUORO, AND IT WAS AT THIS POINT THEY NOTED THE PNEUMOTHORAX. THE PHYSICIAN FEELS THE MONARCH CAUSED THE PNEUMOTHORAX, CONVERTED TO MANUAL SCOPE, AND SUCCESSFULLY COMPLETED THE CASE. A CHEST TUBE WAS PLACED, AND THE PATIENT DISCHARGED THE SAME DAY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/19/2023;04/19/2023" } ] }