{ "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": 26 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "*", "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": "2020563-2020-00003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "K093891", "date_of_event": "20200522", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "501", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "USER FACI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "643752", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200622", "brand_name": "CANON", "generic_name": "SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED", "manufacturer_d_name": "CANON MEDICAL SYSTEMS CORPORATION", "manufacturer_d_address_1": "1385 SHIMOISHIGAMI", "manufacturer_d_address_2": "", "manufacturer_d_city": "OTAWARA-SHI,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "324-8", "manufacturer_d_zip_code_ext": "550", "manufacturer_d_country": "JA", "manufacturer_d_postal_code": "324-8550", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TSX-301A/2D", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "JAK", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, X-Ray, Tomography, Computed", "medical_specialty_description": "Radiology", "regulation_number": "892.1750", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20200622", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10179464", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200528", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "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": "195962689", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "TO ENSURE SAFETY, PRECAUTIONS TO BE OBSERVED ARE PROVIDED IN THE OPERATION MANUAL. EXCERPT FROM THE OPERATION MANUAL (2B201-617EN): THE PATIENT MUST BE IMMOBILIZED AT LEAST TWO LOCATIONS: ELBOWS AND KNEES. IT WAS CONCLUDED THAT THE PHENOMENON WAS CAUSED BY \"USER ERROR\". THIS EVENT OCCURRED DUE TO IMMOBILIZING BANDS NOT BEING USED AT THE KNEES, WHICH IS MENTIONED IN THE OPERATION MANUAL." }, { "mdr_text_key": "195962690", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED A PATIENT KICKED THE MYLAR RING DURING EXAM, MAKING CONTACT WITH THE OPTICS ASSEMBLY. PATIENT'S KNEE WAS INJURED AND IT WAS REPORTED PATIENT UNDERWENT SURGERY. THE EXTENT OF THE INJURIES HAS NOT BEEN OBTAINED AFTER MULTIPLE FOLLOW UP ATTEMPTS. PATIENT WAS REPORTED TO BE KYPHOTIC, WITH LIMITED MENTAL CAPACITY. SCAN IMAGES PRIOR TO THE INJURY DEMONSTRATE THE PATIENT WAS ON THEIR BACK WITH THEIR LEGS BENT AT THE HIP, AT AN 80 TO 90 DEGREE ANGLE. A SINGLE RESTRAINT WAS USED, ONE WIDE STRAP ACROSS MID SECTION OF PATIENT. THE KNEES WERE NOT FIXED. NO ERRORS OCCURRED ON THE SYSTEM DURING OR LEADING UP TO THIS ADVERSE EVENT. THE MYLAR RING WAS REPLACED." } ], "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": "" } ] }