{ "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": "51060571", "event_type": "Injury", "report_number": "3014447948-2022-00022", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220815", "manufacturer_address_2": "", "pma_pmn_number": "K193534", "date_of_event": "20220707", "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": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "510", "date_added": "20220815", "manufacturer_contact_f_name": "HARMINDER", "device_date_of_manufacturer": "20220310", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1237418", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220815", "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": "20221010", "model_number": "MBR-000211-A", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220722", "device_report_product_code": "QNW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MBR000211A1", "udi_public": "+B634MBR000211A1/14D20221010/", "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": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/07/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250806", "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": "20220815", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20220815", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15230044", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220707", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "297950484", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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. A THOROUGH VISUAL INSPECTION, BOTH EXTERNALLY AND INTERNALLY WITH A BAROSCOPE, FOUND NO MISSING PARTS OR PIECES THAT WOULD ACCOUNT FOR A WHITE FB THAT COULD HAVE BEEN FROM THE SCOPE. IT WAS REQUESTED THAT THE CUSTOMER SEND BACK THE ¿WHITE FB¿ PIECE FOR FAILURE ANALYSIS INVESTIGATION. HOWEVER, THE CUSTOMER HAD DISCARDED THE WHITE FB. THE FLUIDICS TUBING AND AURIS FORCEPS WERE ALSO DISCARDED BEFORE BEING RETURNED FOR INVESTIGATION. A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCT FINAL ACCEPTANCE TESTING REVEALED ALL ACCEPTANCE CRITERIA WERE MET AND NO ANOMALIES FOUND. BASED ON THE RESULTS FROM THE EXAMINATION, THE PRODUCT MET SPECIFICATIONS. A REVIEW OF INVESTIGATIONS HAS NOTED THAT THIS IS AN ISOLATED ISSUE AND HAS NO ESTABLISHED A ROOT CAUSE." }, { "mdr_text_key": "297950485", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY." }, { "mdr_text_key": "331693830", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H10: THE REPORTED ISSUE OCCURRED ON A DEVICE USED FOR DIAGNOSIS AND NOT TREATMENT. BECAUSE THE REPORTED ISSUE IS ASSOCIATED WITH SCOPE PERFORMANCE, AN EXAMINATION OF THE SUBJECT SCOPE WAS PERFORMED. THE CUSTOMER REPORTED THAT WHEN THE CUSTOMER INTRODUCED RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE IT PUSHED A PIECE OF WHITE PLASTIC OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. CUSTOMER WAS ABLE TO REMOVE A PIECE OF PLASTIC WITH FORCEPS AND WAS ABLE TO COMPLETE THE CASE. A REVIEW OF COMPLAINT HISTORY REPORTED ISSUE (FRAGMENT FELL IN PATIENT) HAS NOTED THAT THIS IS AN ISOLATED ISSUE AND THE FIRST EVENT OF ITS KIND BUT HAS NOT ESTABLISHED A ROOT CAUSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "510", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/31/2022" } ] }