{ "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": "MRS.", "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": "3014447948-2023-00025", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20231025", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20230925", "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": "NACHBAR", "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": "20231025", "manufacturer_contact_f_name": "MONICA", "device_date_of_manufacturer": "20210620", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2111011", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20231025", "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": "No", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "B634MON0000060", "udi_public": "+B634MON0000060/16D20210620", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Electrical Shorting", "Insufficient Device Problem Information", "Device Handling Problem", "Material Split, Cut or Torn", "Electrical Shorting", "Insufficient Device Problem Information", "Device Handling Problem", "Material Split, Cut or Torn" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/22/2023;11/22/2023", "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": "6282", "patient": [ { "patient_sequence_number": "1", "date_received": "20231025", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "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": "20231025", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "18008095", "removal_correction_number": "", "number_devices_in_event": "", "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": "338140493", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ENGINEERING REVIEWED THE SYSTEM LOGS AND DETERMINED THAT THE ASSOCIATED SYSTEM FAULT INDICATED AN ISSUE WITH FIELD GENERATOR RECOGNITION. FAILURE ANALYSIS WAS PERFORMED ON BOTH THE FIELD GENERATOR AND A SYSTEM PRINTED CIRCUIT BOARD (PCB) ASSOCIATED WITH RECOGNITION OF THE FIELD GENERATOR. THE DEVICE HISTORY RECORD (DHR) REVIEWS FOR THE PCB AND FIELD GENERATOR SHOWED NO NONCONFORMING ISSUES RELATED TO THE PRODUCT OR REPORTED INCIDENT. THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR THE (PCB) DETERMINED THAT A RESISTOR ON THE PCB WAS DAMAGED. THE OEM CONCLUDED THAT A POTENTIAL CAUSE OF THE BROKEN RESISTOR WAS OVERVOLTAGE FROM AN EXTERNAL SOURCE. CORRESPONDINGLY, AURIS ENGINEERING FOUND THAT THE FIELD GENERATOR CABLE WAS DAMAGED WITH TORN INSULATION, GROUNDING SHIELD; AND EXPOSED WIRES OBSERVED. AURIS ENGINEERING CONCLUDED THAT THE EXPOSED WIRES LIKELY CONTACTED ONE ANOTHER ALONG WITH CONTACTING THE CABLE ASSEMBLY GROUND SHIELD AND CREATED A SHORT CIRCUIT CAUSING AN IRREVERSIBLE DAMAGE TO THE PCB. THE EXCESSIVE DAMAGE ON THE CABLE ASSEMBLY IS A RESULT OF THE FIELD GENERATOR CABLE BEING CRUSHED AND EXPERIENCED EXTREME STRAIN, WHICH IS MOST LIKELY DUE TO MISHANDLING AT THE CUSTOMER SITE. ROOT CAUSE FOR THE FAILURE IS TRACED TO USER ERROR. THE INCIDENT WILL CONTINUE TO BE MONITORED IN REGULAR TREND REVIEW MEETINGS. G1. MANUFACTURER CONTACT PHONE NUMBER: (B)(4)." }, { "mdr_text_key": "326555051", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, AURIS HEALTH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "326555052", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A SYSTEM FAULT OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE AND TO RESCHEDULE THE PROCEDURE FOR ANOTHER DAY. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT." } ], "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": "11/22/2023;11/22/2023" } ] }