{
  "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,
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  },
  "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": "2950679-2014-00002",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20140522",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K122137",
      "date_of_event": "20130723",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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        "Health Professional"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20140609",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "306826",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20140522",
          "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": "NA",
          "catalog_number": "NA",
          "lot_number": "NA",
          "other_id_number": "NA",
          "device_availability": "No",
          "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": [
        "Unexpected Therapeutic Results"
      ],
      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250725",
      "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": "20140522",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "76 YR",
          "patient_sex": "",
          "patient_weight": "88",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Cancer"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20140411",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3853142",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20140411",
      "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": "12160706",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "RADIOTHERAPY TREATMENT FOR PROSTATE CANCER HAS AN APPROXIMATE FIVE PERCENT RISK OF CONTRIBUTING TO SUBSEQUENT BLADDER CANCER. WHILE IT IS NOT POSSIBLE TO MAKE A DEFINITIVE DETERMINATION AS TO THE ROOT CAUSE OF THE BLADDER CANCER, THE PRIOR PROSTATE RADIOSURGERY TREATMENT CANNOT BE RULED OUT. (B)(4)."
        },
        {
          "mdr_text_key": "4658370",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A CLINICAL RESEARCH SITE REPORTED THAT STUDY PT (B)(6) RECEIVED CYBERKNIFE TREATMENT FOR PROSTATE CANCER ON (B)(6) 2009. IN (B)(6) 2013, THE PT WAS DIAGNOSED WITH A GRADE 3 PAPILLARY BLADDER TUMOR."
        }
      ],
      "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": ""
    }
  ]
}