{ "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": "3014447948-2023-00019", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230825", "manufacturer_address_2": "", "pma_pmn_number": "K203614", "date_of_event": "20230801", "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": "20230825", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20230504", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1055515", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230825", "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": "MBR-000211-A", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230814", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MBR000211A1", "udi_public": "+B634MBR000211A1/14D202312044", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Device Damaged by Another Device", "No Apparent Adverse Event", "Device Damaged by Another Device", "No Apparent Adverse Event" ], "reporter_state_code": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/25/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250827", "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": "20230825", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "47 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230927", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "17626992", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230801", "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": "336668096", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FAILURE ANALYSIS HAS CONCLUDED THAT THE REPORTED ISSUE WAS UNINTENTIONALLY CAUSED BY THE USER BY NOT FULLY ENGAGING THE JAWS OF THE FORCEPS USED DURING THE PROCEDURE. A REVIEW OF SIMILAR INVESTIGATIONS WITH SIMILAR REPORTED ISSUE HAS NOTED THAT THIS IS AN ISOLATED INCIDENT. THE INCIDENT WILL CONTINUE TO BE MONITORED IN REGULAR TREND REVIEW MEETINGS." }, { "mdr_text_key": "321990158", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY THE PHYSICIAN REMOVED A FOREIGN OBJECT WHILE WITHDRAWING THE SPECIMEN TISSUE FROM THE SPECIMEN." } ], "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": "09/27/2023" } ] }