{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 1951 } }, "results": [ { "manufacturer_contact_zip_ext": "507", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MR", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "KUROISHI-SHI, AOMORI", "manufacturer_contact_address_1": "2951 ISHIKAWA-CHO", "manufacturer_contact_pcity": "42642517", "event_type": "Injury", "report_number": "8010047-2020-05537", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200817", "manufacturer_address_2": "", "pma_pmn_number": "K151743", "date_of_event": "20200529", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "192-8", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "426425177", "noe_summarized": "1", "manufacturer_contact_l_name": "MATSUMOTO", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "036-0357", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "426", "date_added": "20200817", "manufacturer_contact_f_name": "KAZUTAKA", "device_date_of_manufacturer": "20191205", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "878178", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20200817", "brand_name": "THUNDERBEAT OPEN FINE JAW", "generic_name": "ULTRASONIC SURGICAL DEVICE", "manufacturer_d_name": "AOMORI OLYMPUS CO., LTD.", "manufacturer_d_address_1": "2-248-1 OKKONOKI", "manufacturer_d_address_2": "", "manufacturer_d_city": "KUROISHI-SHI, AOMORI", "manufacturer_d_state": "", "manufacturer_d_zip_code": "036-0", "manufacturer_d_zip_code_ext": "357", "manufacturer_d_country": "JA", "manufacturer_d_postal_code": "036-0357", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TB-0009OF", "catalog_number": "", "lot_number": "9ZK", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200806", "device_report_product_code": "GEI", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "04953170343346", "udi_public": "04953170343346", "openfda": { "device_name": "Electrosurgical, Cutting & Coagulation & Accessories", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4400", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/21/2020;10/06/2020;12/19/2023;05/02/2024", "mfr_report_type": "", "manufacturer_contact_country": "JA", "date_changed": "20250727", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "357", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4264", "patient": [ { "patient_sequence_number": "1", "date_received": "20200817", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20240502", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "JA", "manufacturer_contact_city": "HACHIOJI-SHI, TOKYO-TO", "mdr_report_key": "10418445", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200727", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "036-0", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "AOMORI OLYMPUS CO., LTD.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321247648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 11.5 MM FROM THE DISTAL END. THE PROBE HAD A MARK CONTACTED WITH THE GRASPING SECTION. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED FROM THE CONTACT MARK. THE GRASPING SECTION WAS BROKEN OFF AT 13 MM FROM THE DISTAL END. THE GRASPING SECTION HAD A MARK CONTACTED WITH THE PROBE. THE TISSUE PAD WAS WORN AND THE PROXIMAL SIDE OF IT WAS SEPARATED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE TISSUE PAD AT THE PROXIMAL SIDE WAS DAMAGED SINCE THE USER ACTIVATED OUTPUT WHILE THE SUBJECT DEVICE WAS GRASPING A THICK AND HARD TISSUE. IT WAS ALSO KNOWN THAT THE PROXIMAL SIDE OF THE GRASPING SECTION AND THE PROBE CAME INTO CONTACT SINCE THE TISSUE PAD AT THE PROXIMAL SIDE WAS DAMAGED, CONSEQUENTLY THE PROBE CRACKED, AND BESIDES THE PROBE WAS BROKEN OFF WHEN THE PROBE WAS SUBJECTED TO A LOAD. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL." }, { "mdr_text_key": "320204744", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION AND WE CONFIRMED THAT THE PROBE WAS BROKEN OFF. IN ADDITION, THE TISSUE PAD WAS SEPARATED. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME." }, { "mdr_text_key": "212526428", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME." }, { "mdr_text_key": "212526429", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING AN OTORHINOLARYNGOLOGICAL SURGERY, THE SUBJECT DEVICE WAS USED. AFTER MORE THAN 2 HOURS SINCE THE SURGERY BEGAN, PROBE DAMAGE ERROR OCCURRED AND THE PROBE OF THE SUBJECT DEVICE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE PROBE." }, { "mdr_text_key": "341799288", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9614641." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2-248-1 OKKONOKI", "distributor_zip_code": "", "manufacturer_contact_postal_code": "192-8507", "manufacturer_contact_exchange": "426", "manufacturer_contact_pcountry": "081", "suppl_dates_fda_received": "09/13/2020;10/26/2020;01/16/2024;05/02/2024" } ] }