{ "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": "3014447948-2022-00006", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220603", "manufacturer_address_2": "", "pma_pmn_number": "K193534", "date_of_event": "20220506", "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": [ "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": "20220603", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20211004", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1801472", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220603", "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": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MON0000060", "udi_public": "+B634MON0000060/16D20211004", "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": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250728", "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": "20220603", "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": "20220603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "14593373", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220506", "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": "293274328", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING THE SECOND CASE OF THE DAY THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). NO CHEST TUBE WAS PLACED; HOWEVER, THE PATIENT WAS ADMITTED FOR OBSERVATION AND PLACED ON OXYGEN DUE TO THE PATIENT HAVING HAD INCIDENTAL ABNORMAL LIVER FUNCTION AND NEEDED ADDITIONAL WORK UP NOT RELATED TO PNEUMOTHORAX. THE PATIENT HAS BEEN DISCHARGED." }, { "mdr_text_key": "293274329", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ET TUBE WAS POSITIONED 27MM FROM THE MAIN CARINA. THE USER MANUAL STATES ¿IN ORDER TO FACILITATE NAVIGATION INITIALIZATION, THE ENDOTRACHEAL TUBE SHOULD BE PLACED NO CLOSER THAN 40 MM FROM THE MAIN CARINA AND SHOULD OPEN DIRECTLY TOWARD THE MAIN CARINA.¿ DURING THE FIRST RUN, THE PHYSICIAN/USER DROVE TO THE UPPER LOBE BRONCHUS. THE VIRTUAL BRONCH VIEW SHOWED AN IMAGE ADVISING THE PHYSICIAN/USER TO TURN DOWN TO RB2, HOWEVER THE PHYSICIAN/USER TURNED RIGHT UP INTO RB1. THE PHYSICIAN/USER STAYED IN RB1 AT THE INTERSECTION OF RB1A AND RB1B AND THE NAVIGATION (FUSION) JUMPED BETWEEN THE PLANNED PATH LOCATION IN RB2 AND THE TRUE SCOPE LOCATION IN RB1. THE ANATOMICAL DEFORMATION WAS CAUSED OFF-PATH DRIVING AND BUCKLING DUE TO THE TIGHT TURN. THE PHYSICIAN/USER RETRACTED AND STARTED A SECOND RUN. A SLIGHT ROTATION IN REGISTRATION MATRIX MAY HAVE CONTRIBUTED TO THE ¿NAVIGATION FALLING OFF¿ EXPERIENCED BY THE PHYSICIAN/USER, CAUSING THE DIRECTION OF THE REGISTERED EM TO BE SLIGHTLY INACCURATE. JUMPINESS WAS NOTED AT 30MM FROM THE TARGET IN OUTSIDE SEGMENTATION MODE WHERE NAVIGATION (FUSION) WAS DRIVEN SOLELY BY EM SIGNAL. THE PHYSICIAN/USER TOOK THE BIOPSIES FROM THREE DIFFERENT SCOPE POSITIONS WHERE LATERAL/INSERTION EXCURSION OF SCOPE DISTAL WERE NOTED ACCOMPANYING TOOL PASSAGE WITHOUT RECOMMENDED ROBOTIC ARTICULATION; THE MOVEMENT OF SCOPE TIP WAS WITHIN SPECIFICATION (+/- 10 DEGREES OF ANGULATION) AFTER A WORKING CHANNEL INSTRUMENT WAS ADVANCED THROUGH IT (BRONCH_2-SSS-36). THE SCOPE TIP MOTION DID NOT GO BEYOND WHERE THE PHYSICIAN/USER EXTENDED THE WORKING CHANNEL TOOLS AND IS THEREFORE UNLIKELY THE CAUSE OF THE PATIENT¿S PNEUMOTHORAX. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO ALGORITHM LIMITATION: EM REGISTRATION (INABILITY TO COMPENSATE FOR DEFORMATION CAUSED BY BUCKLING DUE TO TIGHT TURN; ROTATION IN REGISTRATION MATRIX DUE TO IMPROPER ET TUBE SETUP). UNEXPECTED SCOPE MOTION WAS WITHIN SPECIFICATION BASED ON 105-000357-00 REV F, BRONCH_2-SSS-36. A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCT FINAL ACCEPTANCE TESTING REVEALED ALL ACCEPTANCE CRITERIA WERE MET AND NO ANOMALIES FOUND. BASED ON THE RESULTS FROM THE EXAMINATION, THE PRODUCT MET SPECIFICATIONS. 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." } ], "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": "" } ] }