{ "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": "3014447948-2022-00035", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20221005", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20220901", "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": "20221005", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20211004", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2045762", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20221005", "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": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Product Quality Problem", "Product Quality Problem" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/27/2022", "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": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20221005", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20221005", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15546974", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220927", "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": "301233799", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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." }, { "mdr_text_key": "301233800", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A MONARCH BRONCHOSCOPY CASE, AT APPROXIMATELY 3:20 PM, THERE WAS A NAVIGATION FUSION ERROR (FAULT 1224) THAT REQUIRED THE USER TO RE-REGISTER. THE NAVIGATION ERROR (FAULT 1224) OCCURRED 58MM AWAY FROM THE ENDOBRONCHIAL TUMOR AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S PROCEDURE-RELATED INJURY. THE FAULT MESSAGE ON THE CART: FAULT ID 711-50-0-0: SCOPE DISCONNECTED WAS REPORTED DUE TO THE BRONCHOSCOPE BEING REMOVED FROM THE PATIENT. THE USE OF THE MONARCH SYSTEM WAS ENDED TO CONTROL BLEEDING. THE CUSTOMER USED COLD SALINE AND TAMPONADE TO CONTROL THE BLEEDING. THE PHYSICIAN STATED THE BLEEDING WAS NOT CAUSED FROM THE MONARCH DEVICE, IT WAS CAUSED FROM A UNIQUE TYPE OF ENDOBRONCHIAL TUMOR THE PATIENT HAD AND WAS BLEEDING FROM THIS TUMOR. AFTER THE BLEEDING WAS CONTROLLED, THE PHYSICIAN SAMPLED THE LYMPH NODES VIA EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY). IT REQUIRED TWO REBOOTS TO RESOLVE ERROR AND ENABLE USER TO MOVE FORWARD WITH MONARCH PROCEDURE AND COMPLETE CASE SUCCESSFULLY." }, { "mdr_text_key": "333447639", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED ISSUE WAS REGARDING ¿NAVIGATION FUSION ERROR AND FAULT ID 711-50-0-0: SCOPE DISCONNECTED¿. FAULT 1224 (NAVIGATION FUSION ERROR) IS A LOGICAL ERROR IN FUSION. THE REPORTED FAULT 1224 WAS ATTRIBUTED A SOFTWARE BUG. MODEF-2565 WAS CREATED TO CAPTURE THIS FAILURE MODE. IT WILL BE ADDRESSED VIA FUTURE SOFTWARE RELEASE. THE FAULT 711 OCCURRED FOLLOWING THE DISCONNECTION OF THE SCOPE. THIS IS A MINOR SYSTEM FAULT THAT IS TRIGGERED WHEN THE BRONCHOSCOPE CABLE IS DISCONNECTED FROM THE MONARCH TOWER PRIOR TO PRESSING STOP PROCEDURE. THE MONARCH SYSTEM WAS FUNCTIONING AS INTENDED BY DISPLAYING THE ERROR MESSAGE TO THE USER WHEN THE CONDITION WAS DETECTED. MONARCH PLATFORM USER MANUAL 2.0, 300-011197-00, REV E, PAGE 129 . 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. THE RISK ASSOCIATED WITH THIS FAILURE IS DOCUMENTED IN: RISK DOCUMENT NUMBER: 105-000369-00 REV K DFMEA BRONCH 2.0 105-000366-00 REV I THERE IS NO CONNECTION BETWEEN PATIENT INJURY AND THE DEVICE FAULT REPORTED." } ], "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": "11/04/2022" } ] }