{ "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": "", "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": "2950679-2013-00006", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130507", "manufacturer_address_2": "", "pma_pmn_number": "K091999", "date_of_event": "20070701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NOT APPLICABLE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Study", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130515", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "197926", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130507", "brand_name": "CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM", "generic_name": "CYBERKNIFE SYSTEM", "manufacturer_d_name": "ACCURAY, INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "CYBERKNIFE", "catalog_number": "NA", "lot_number": "NA", "other_id_number": "NA", "device_availability": "Yes", "device_report_product_code": "IYE", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Accelerator, Linear, Medical", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20130507", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " S" ], "patient_age": "NA", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Ulcer" ] } ], "distributor_city": "", "date_report": "20130411", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3111113", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20130411", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Modification/Adjustment" ], "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": "3424593", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 04/11/2013 WHILE READING A DRAFT RESEARCH PAPER ENTITLED \"STEREOTACTIC BODY RADIATION THERAPY FOR HEPATOCELLULAR CARCINOMA; PROGNOSTIC FACTORS OF LOCAL CONTROL, OVERALL SURVIVAL, AND TOXICITY\"; AN ACCURAY EMPLOYEE BECAME AWARE OF AN ADVERSE EVENT. 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NO SYSTEMIC OR SAFETY ISSUES IDENTIFIED." } ], "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": "" } ] }