{ "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. 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"number_devices_in_event": "", "date_manufacturer_received": "20210603", "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": "328008596", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT NOTIFIED THE PULMONOLOGY TEAM AT THE HOSPITAL TO PICK UP THE OXYGEN EQUIPMENT AS THE PATIENT DISCONTINUED OXYGEN THERAPY AND ASKED THAT THE EQUIPMENT BE PICKED UP." }, { "mdr_text_key": "259464887", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS EVENT WAS REPORTED FROM THE TRANSBRONCHIAL BIOPSY ASSISTED BY ROBOT GUIDANCE IN THE EVALUATION OF TUMORS OF THE LUNG (TARGET) STUDY (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4), REV E, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING." }, { "mdr_text_key": "259464888", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX AND A PARTIAL COLLAPSED LUNG. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT LOWER LOBE. A PIGTAIL CATHETER WAS PLACED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE PATIENT EXPERIENCED SOME PAIN AROUND THE CATHETER, AND THIS RADIATED TO THE PATIENTS BACK. 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