{ "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": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DRIVE", "manufacturer_contact_pcity": "65020852", "event_type": "Injury", "report_number": "3014447948-2023-00018", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230824", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230727", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6502085208", "noe_summarized": "1", "manufacturer_contact_l_name": "NACHBAR", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "650", "date_added": "20230824", "manufacturer_contact_f_name": "MONICA", "device_date_of_manufacturer": "20210831", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1639771", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230824", "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": "Y", "combination_product_flag": "N", "udi_di": "B634MON000005010", "udi_public": "+B634MON000005010/16D20210831", "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", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/22/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250811", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6502", "patient": [ { "patient_sequence_number": "1", "date_received": "20230824", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "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": "20230824", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "17618092", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230727", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "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": "336668781", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ENGINEERING CONFIRMED THE REPORTED EVENT OF BLEEDING THROUGH INVESTIGATION OF THE PROCEDURE VIDEO. A REVIEW OF THE PROCEDURE VIDEO BY CLINICAL ENGINEERING DID NOT FIND EVIDENCE THAT THE MONARCH BRONCHOSCOPE CAUSED ANY DAMAGE TO THE AIRWAYS, CAUSING THE BLEEDING. THE ROOT CAUSE OF THE BLEEDING IS NOT CLEAR FROM THE VIDEO. INVESTIGATION OF SYSTEM LOGS BY FAILURE ANALYSIS ENGINEERING CONCLUDED THAT THE MONARCH SYSTEM BEHAVED AS INTENDED. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE SYSTEM WAS PERFORMED AND NO NON-CONFORMANCES WERE FOUND THAT RELATE TO THE REPORTED ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED IN REGULAR TREND REVIEW MEETINGS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO SUPPORT THAT THE MONARCH SYSTEM CAUSED THE BLEEDING DESCRIBED." }, { "mdr_text_key": "321925631", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, BLEEDING WAS NOTED. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRADITIONAL BRONCHOSCOPY AND A BALLOON WAS USED TO PROVIDE TAMPONADE. PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE PATIENT BLEED WAS DUE TO THE PATIENT¿S FRAGILE AIRWAYS AND PRE-EXISTING CONDITION. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO HOSPITALIZATION REQUIRED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "650", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/25/2023" } ] }