{ "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": "62825447", "event_type": "Injury", "report_number": "3014447948-2023-00035", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240129", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240104", "reprocessed_and_reused_flag": "Y", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6282544750", "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": "628", "date_added": "20240129", "manufacturer_contact_f_name": "HARMINDER", "device_date_of_manufacturer": "20231020", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1648573", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240129", "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": "20240420", "model_number": "MBR-000211-B", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240109", "device_report_product_code": "QNW", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MBR000211B1", "udi_public": "+B634MBR000211B1/14D20240420E", "openfda": { "device_name": "Reprocessed Bronchoscope", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Deformation Due to Compressive Stress", "Deformation Due to Compressive Stress" ], "reporter_state_code": "DE", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "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": "6282", "patient": [ { "patient_sequence_number": "1", "date_received": "20240129", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20240129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "18597523", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240129", "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": "333980822", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT IS BASED ON INFORMATION WHICH HAS BEEN INVESTIGATED OR VERIFIED. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED PNEUMOTHORAX IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING. A VISUAL EXAMINATION OF THE SCOPE HANDLE, SHAFT, AND TIP OBSERVED NO EXTERNAL DAMAGE EXCEPT OBSERVED KINK IN THE SCOPE JACKET 10MM FROM THE SCOPE HANDLE. A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCTION FINAL ACCEPTANCE TESTING REVEALED ALL ACCEPTANCE CRITERIA WERE MET AND NO ANOMALIES FOUND. BASED ON THE RESULTS FROM THE EXAMINATION, THE BRONCHOSCOPE DID NOT MEET SPECIFICATIONS DUE TO OBSERVED KINK ON SCOPE JACKET." }, { "mdr_text_key": "333980823", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "628", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }