{ "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": "MR.", "manufacturer_contact_state": "WI", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MADISON", "manufacturer_contact_address_1": "1209 DEMING WAY", "manufacturer_contact_pcity": "60882429", "event_type": "Injury", "report_number": "3003873069-2022-00013", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220721", "manufacturer_address_2": "", "pma_pmn_number": "K170788", "date_of_event": "20140101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "53717", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "6088242971", "noe_summarized": "1", "manufacturer_contact_l_name": "BIANK", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "53717", "manufacturer_g1_state": "WI", "reporter_country_code": "US", "manufacturer_contact_area_code": "608", "date_added": "20220721", "manufacturer_contact_f_name": "DANIEL", "device_date_of_manufacturer": "20200611", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "252181", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220721", "brand_name": "CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM", "generic_name": "MEDICAL LINEAR ACCELERATOR", "manufacturer_d_name": "ACCURAY INCORPORATED", "manufacturer_d_address_1": "1209 DEMING WAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "MADISON", "manufacturer_d_state": "WI", "manufacturer_d_zip_code": "53717", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "53717", "device_operator": "HEALTH PROFESSIONAL", "model_number": "G4", "catalog_number": "NA", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "IYE", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "M6580330000", "udi_public": "+M6580330000/16D20180611B", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/02/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250806", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6088", "patient": [ { "patient_sequence_number": "1", "date_received": "20220721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Incontinence" ] } ], "distributor_city": "", "date_report": "20220926", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MADISON", "mdr_report_key": "15078585", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "296346394", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INITIAL INVESTIGATION IS THAT NO MALFUNCTION OCCURRED, AND THIS IS A KNOWN EXPECTED SIDE EFFECT; HOWEVER, THE INVESTIGATION IS ONGOING, AND A FINAL INVESTIGATION WILL BE PROVIDED ONCE COMPLETE." }, { "mdr_text_key": "296346395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT CONTACTED ACCURAY AND PROVIDED THE FOLLOWING INFORMATION: HAD CYBERKNIFE TREATMENT IN 2014 AT (B)(6) HOSPITAL. SHORTLY AFTER THE TREATMENT THE I HAD URINARY INCONTINENCE FOLLOWED BY LATER FECAL INCONTINENCE. BOTH ARE UNCONTROLLABLE. THERE ARE SURGERIES TO HELP CORRECT THIS PROBLEM HOWEVER I DO NOT WISH TO GO THIS ROUTE AND VERY DISSATISFIED WITH THE OUTCOME." }, { "mdr_text_key": "331224561", "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. URINARY AND FECAL INCONTINENCE ARE KNOWN ACUTE AND LATE GENITOURINARY AND GASTROINTESTINAL 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." } ], "number_patients_in_event": "", "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" } ] }