{ "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 DRIVE", "manufacturer_contact_pcity": "62825447", "event_type": "Injury", "report_number": "3014447948-2024-00003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240312", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20240215", "reprocessed_and_reused_flag": "N", "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": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "628", "date_added": "20240312", "manufacturer_contact_f_name": "HARMINDER", "device_date_of_manufacturer": "20220510", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721230", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240312", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240222", "device_report_product_code": "EOQ", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MON0000060", "udi_public": "+B634MON0000060/16D20220510", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Mechanical Jam", "Mechanical Jam" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250818", "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": "20240312", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "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": "20240312", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "18889316", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240311", "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": "337511177", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SUBJECT ARM WAS RETURNED TO AURIS FAILURE ANALYSIS ENGINEERING, AND AFTER EXTENSIVE TESTING, THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE IS TRACED TO DEVICE DESIGN, SPECIFICALLY THE DESIGN OF THE IDM TOP PLATE SEAL FOR CAUSING HIGH FRICTION, AND THUS AN INCREASED TORQUE ON THE IDM ROLL JOINT. THE SUPPLIER KINOVA FOUND THAT SOME ARMS MIGHT BE AFFECTED BY A FIRMWARE (FW) BUG IN THE ROLL TORQUE CALIBRATION SCRIPT. THE BUG¿S IMPACT IS DEPENDENT ON THE AMPLITUDE OF THE CALIBRATION JIG¿S LOAD OFFSET AND IMPACTS THE ROLL AXIS FAIN AND OFFSET. THIS WOULD CAUSE THE FW TO OVERESTIMATE THE TORQUE FELT, SINCE THE IDM MAX TORQUE SAFETY (3.29NM THRESHOLD) WOULD TRIGGER WHEN AROUND 2.3NM WAS APPLIED. THE SUBJECT ROBOTIC ARM, WITH SN (B)(6), WAS FOUND TO BE LISTED ON THE IMPACTED IDMS, THEREFORE THIS ISSUE CAN ALSO BE TRACED MANUFACTURING. THERE WAS ALSO DAMAGE OBSERVED TO THE IDM TOP PLATE OF THE ARM, WHICH COULD CONTRIBUTE TO THE INCREASED FRICTION, ALTHOUGH IT COULD NOT BE CONFIRMED HOW THIS DAMAGE OCCURRED. THE SUBJECT ARM WAS REPLACED, AND THE CUSTOMER SITE HAS NOT EXPERIENCED ISSUES SINCE." }, { "mdr_text_key": "337511178", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY, THE PHYSICIAN BIOPSIED SAMPLES AT THE RIGHT UPPER LOBE (RUL) 3CM FROM THE TARGET. AS THE PHYSICIAN REPOSITIONED THE BRONCHOSCOPE, A ROBOTIC ARM FAULT STATE OCCURRED. THE PHYSICIAN WAS NOT ABLE TO GET ALL OF HIS BIOPSIES DUE TO THIS FAULT CONDITION AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "628", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }