{ "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": "3014447948-2023-00021", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230907", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230808", "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": "20230907", "manufacturer_contact_f_name": "MONICA", "device_date_of_manufacturer": "20210922", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2201427", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230907", "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": "B634MON000005010", "udi_public": "+B634MON000005010/16D20210922", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Application Program Problem", "Insufficient Device Problem Information", "Application Program Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/06/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20230907", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230907", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "17703360", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230808", "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": "338349316", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ENGINEERING DETERMINED THAT THE NAVIGATIONAL DIFFICULTY WAS DUE TO A SOFTWARE ALGORITHM LIMITATION THAT FAILED TO SEGMENT THE PATIENT ANATOMY CORRECTLY. THE ALGORITHM LIMITATION LEAD TO THE POOR VIRTUAL VIEW RENDING NEAR THE TARGET. 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. NO FURTHER ACTION IS NEEDED BASED ON THE RISK ACCEPTANCE. THIS ISSUE WILL BE TRACKED AND TRENDED IN THE MONTHLY COMPLAINT TREND REVIEW MEETINGS." }, { "mdr_text_key": "322889998", "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, THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE DUE TO NAVIGATIONAL DIFFICULTY. THE PATIENT WAS REPORTED TO HAVE A LOT OF MUCUS. THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO MEDICAL OR SURGICAL INTERVENTION REPORTED. 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": "10/06/2023" } ] }