{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 31113 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2951238-2020-00436", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20200402", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20200402", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "475181", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200429", "brand_name": "EVIS EXERA III BRONCHOVIDEOSCOPE", "generic_name": "BRONCHOVIDEOSCOPE", "manufacturer_d_name": "OLYMPUS MEDICAL SYSTEMS CORP.", "manufacturer_d_address_1": "2951 ISHIKAWA-CHO", "manufacturer_d_address_2": "", "manufacturer_d_city": "HACHIOJI-SHI, TOKYO-TO", "manufacturer_d_state": "", "manufacturer_d_zip_code": "192-8", "manufacturer_d_zip_code_ext": "507", "manufacturer_d_country": "JA", "manufacturer_d_postal_code": "192-8507", "device_operator": "HEALTH PROFESSIONAL", "model_number": "BF-P190", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200308", "device_report_product_code": "EOQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "04953170342110", "udi_public": "04953170342110", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Leak/Splash", "Material Split, Cut or Torn" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250817", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "55", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200402", "manufacturer_contact_city": "", "mdr_report_key": "10009358", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "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": "189496104", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SERVICE CENTER WAS INFORMED OF A LEAK IN THE SERVICE PORTAL OF THE SCOPE. UPON FOLLOW UP WITH THE USER FACILITY, IT WAS REPORTED THIS WAS FOUND FOLLOWING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND, NAVIGATIONAL BRONCHOSCOPY WITH FINE NEEDLE BIOPSIES. THE PATIENT WAS NOTED TO HAVE DEVELOPED A PNEUMOTHORAX POST PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT SCOPE. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. AS PART OF OUR INVESTIGATION, THE SERVICE CENTER FOLLOWED UP WITH THE USER FACILITY REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE PHYSICIAN WAS EXPERIENCED IN USING THE DEVICE. THE USER FACILITY REPORTS THAT THE SCOPE¿S PRE-CLEANING IS BEING PERFORMED IMMEDIATELY AFTER A PROCEDURE PER OLYMPUS GUIDELINES. THE CLEANING AND DISINFECTANT SOLUTIONS BEING USED WITH THE ENDOSCOPE ARE RAPICIDE AND INTERCEPT. THE ENDOSCOPE CHANNEL IS BEING BRUSHED DURING MANUAL CLEANING WITH A SINGLE-USE OLYMPUS BRUSH. THE ENDOSCOPE IS BEING LEAK TESTED PRIOR TO MANUAL CLEANING. THE LEAK TESTER IS UNKNOWN. THE TYPE OF AER BEING USED TO REPROCESS THE SCOPE IS A MEDIVATOR ESD EDGE12V. THE MINIMUM EFFECTIVE CONCENTRATION IS BEING CHECKED AFTER EACH SCOPE IS PROCESSED. THERE IS FLUSHING OF AIR INTO THE CHANNEL OF THE ENDOSCOPE AFTER REPROCESSING. THERE HAVE NOT BEEN ANY ISSUES NOTED WITH THE AER. A REPROCESSING IN-SERVICE IS PROVIDED EVERY 3 MONTHS. THERE HAS NOT BEEN ANY CHANGE IN THE REPROCESSING PERSONNEL. ALL PERSONNEL ARE TRAINED ON HOW TO PROPERLY REPROCESS AN ENDOSCOPE. THE SCOPES ARE BEING STORED HUNG IN A CABINET WITH VENTILATION. THE ENDOSCOPES HAVE NOT BEEN CULTURED. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE. THE SCOPE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION PERFORMED WITH AN OLYMPUS BOROSCOPE FOUND TEAR MARKS AND LEAK ON THE BIOPSY CHANNEL AT THE BENDING SECTION RUBBER. THE SCOPE WAS FOUND TO HAVE 21USES. A REVIEW OF THE INSTRUMENT¿S HISTORY FOUND THAT THE SCOPE WAS LAST RETURNED FOR SERVICE ON OCTOBER 18, 2019 FOR PHYSICAL DAMAGE AND A LEAK. THE INSTRUCTION MANUAL WARNS USERS ¿¿ NEVER INSERT OR WITHDRAW THE ENDOSCOPE UNDER ANY OF THE FOLLOWING CONDITIONS. PATIENT INJURY, BLEEDING, AND/OR PERFORATION CAN RESULT. ' WHILE THE ENDOTHERAPY ACCESSORY EXTENDS FROM THE DISTAL END OF THE ENDOSCOPE. ' WHILE THE BENDING SECTION IS LOCKED IN POSITION. ' INSERTION OR WITHDRAWAL WITH EXCESSIVE FORCE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }