{ "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": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DR.", "manufacturer_contact_pcity": "51060571", "event_type": "Injury", "report_number": "3014447948-2022-00029", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220907", "manufacturer_address_2": "", "pma_pmn_number": "K203614", "date_of_event": "20220801", "reprocessed_and_reused_flag": "Y", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5106057113", "noe_summarized": "1", "manufacturer_contact_l_name": "KAUR", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "510", "date_added": "20220907", "manufacturer_contact_f_name": "HARMINDER", "device_date_of_manufacturer": "20220225", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1232337", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220907", "brand_name": "MONARCH BRONCHOSCOPE", "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES", "manufacturer_d_name": "AURIS HEALTH, INC.", "manufacturer_d_address_1": "150 SHORELINE DR.", "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", "expiration_date_of_device": "20220925", "model_number": "MBR-000211-A", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "QNW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MBR000211A1", "udi_public": "+B634MBR000211A1/14D20220925E", "openfda": { "device_name": "Reprocessed Bronchoscope", "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": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/12/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5106", "patient": [ { "patient_sequence_number": "1", "date_received": "20220907", "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": "20220914", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15370728", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220808", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "299381972", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING THE FIRST, AND ONLY CASE OF THE DAY (1:45PM), THE RIGHT LOWER LOBE (RLL) LESION 1.5CM EXPECTED INFECTION, PHYSICIAN DID 4 BRUSHES AND PATIENT SUSTAINED A SMALL PNEUMOTHORAX. A CHEST TUBE WAS PLACED TAKING A WEEK TO RESOLVE. AURIS FORCEPS, A MICRO BRUSH (BRAND WAS NOT RECORDED), AND AN OLYMPUS PERIVIEW FLEX TBNA NEEDLE WERE ALL USED IN THIS CASE. PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE MONARCH SYSTEM." }, { "mdr_text_key": "299381973", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "331890372", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A VISUAL EXAMINATION OF THE SCOPE HANDLE, SHAFT, AND TIP OBSERVED NO EXTERNAL DAMAGE. TO VERIFY THE SCOPE LATCHED ONTO THE INSTRUMENT DEVICE MANIPULATOR (IDM), THE SCOPE WAS THEN CONNECTED AND DISCONNECTED TO 2 DIFFERENT IDM TOP PLATES 10X EACH. THE SCOPE WAS THEN CONNECTED AND DISCONNECTED TO 2 DIFFERENT BENCHTOP IDM FIXTURES 10X EACH. THE SCOPE WAS THEN CONNECTED AND DISCONNECTED ONTO AN IN-HOUSE SYSTEM ON BOTH IDMS 10X EACH. NO LATCHING ISSUE WAS OBSERVED. DIMENSIONAL VERIFICATION FOR ANY STRUCTURAL ANOMALIES YIELDED NO VARIANCE OBSERVED. THE SUBJECT SCOPE WAS CONNECTED TO A BENCH TEST FIXTURE TO VERIFY ELECTRICAL FUNCTIONALITY OF THE CAMERA, LIGHT EMITTING DIODE (LED), AND ELECTROMAGNETIC SENSORS (EM). THE RESULTS SHOWED THE BRONCHOSCOPE TO BE OPERATING AS EXPECTED. THE SCOPE WAS THEN CONNECTED TO AN IN-HOUSE SYSTEM AND TO CONFIRM THE FUNCTIONALITY OF THE SCOPE. THE RESULTS SHOWED THE BRONCHOSCOPE TO BE OPERATING AS EXPECTED. BASED ON THE RESULTS FROM THE EXAMINATION, THE MONARCH BRONCHOSCOPE USED ON THE MONARCH PLATFORM HAS MET SPECIFICATIONS AND THERE WERE NO ISSUES FOUND WITH THE MONARCH BRONCHOSCOPE. RISK DOCUMENT NUMBER: 105-000299-01, REV F, MONARCH BRONCHOSCOPE RISK MANAGEMENT REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "510", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/14/2022" } ] }