{
  "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",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
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      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
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        "Followup"
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      "manufacturer_address_2": "",
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      "date_of_event": "20220823",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
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      "manufacturer_contact_plocal": "6088242971",
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      "manufacturer_g1_postal_code": "53717",
      "manufacturer_g1_state": "WI",
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          "serviced_by_3rd_party_flag": "U",
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          "generic_name": "MEDICAL LINEAR ACCELERATOR",
          "manufacturer_d_name": "ACCURAY INCORPORATED",
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          "device_age_text": "DA",
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          "udi_public": "",
          "openfda": {
            "device_name": "Accelerator, Linear, Medical",
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        "Adverse Event Without Identified Device or Use Problem"
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      "reporter_state_code": "CA",
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      "suppl_dates_mfr_received": "08/23/2022",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250801",
      "health_professional": "",
      "summary_report_flag": "N",
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          "patient_sex": "Male",
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          "patient_race": "",
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            "Incontinence",
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        }
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      "distributor_city": "",
      "date_report": "20220926",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MADISON",
      "mdr_report_key": "15395817",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220823",
      "manufacturer_name": "",
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      "remedial_action": [
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      "manufacturer_g1_zip_code": "53717",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "ACCURAY INCORPORATED",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
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      "mdr_text": [
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          "mdr_text_key": "299659687",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "PATIENT EXPERIENCED KNOWN, ADVERSE SIDE EFFECTS FROM RADIATION TREATMENT. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. THE INVESTIGATION IS ON-GOING."
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        {
          "mdr_text_key": "299659688",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "PATIENT EXPERIENCED URINARY AND FECAL RETENTION AND INCONTINENCE AFTER CYBERKNIFE TREATMENTS."
        },
        {
          "mdr_text_key": "331760174",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "AN INTERVIEW WAS CONDUCTED WITH THE PATIENT. A REVIEW OF LITERATURE ON KNOWN SIDE EFFECTS OF EXTERNAL BEAM RADIATION THERAPY FOR THE TREATMENT OF PROSTATE CANCER WAS COMPLETED. IT IS UNKNOWN IF THE PATIENT HAD ANY OTHER RISK FACTORS THAT AFFECTED THE RISK OF DEVELOPING THESE TOXICITIES. THE URINARY AND GASTROINTESTINAL SYMPTOMS DESCRIBED BY THE PATIENT ARE KNOWN ACUTE AND LATE TOXICITIES ASSOCIATED WITH EXTERNAL BEAM RADIATION THERAPY TO THE PROSTATE AND SURROUNDING AREA. A REVIEW OF COMPLAINTS FROM THE SITE THAT THE PATIENT RECEIVED THEIR TREATMENT AT WAS COMPLETED. NO NON-CONFORMITY WAS IDENTIFIED. IN CONCLUSION, NO SYSTEM DEFECT WAS IDENTIFIED DURING THE TIME THE PATIENT RECEIVED TREATMENTS. THE INVESTIGATION DETERMINED THAT THE INDIVIDUAL HAS EXPECTED, KNOWN SIDE EFFECTS FROM RADIATION TREATMENT."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "1209 DEMING WAY",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "53717",
      "manufacturer_contact_exchange": "608",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "09/27/2022"
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}