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| Discovered date | Reporting criterion | Title | Description | LER | |
|---|---|---|---|---|---|
| ENS 57135 | 22 May 2024 13:30:00 | 10 CFR 20.2201(a)(1)(ii) | Lost LUTETIUM-177 Source | The following synopsis was provided by the licensee via phone: On 5/21/24, a 200 millicurie lutetium-177 (Lu-177) source was delivered to the Karmonas Cancer Institute and was placed in a clean hot laboratory. A physics resident cleaning the hot laboratory placed the box containing the source outside the hot lab on a trash can. A custodian threw the box in the trash at the end of the day. The licensee notified the trash management company and the facility security department. No threat to public health is expected based on source packaging. The NRC Region 3 inspector was also notified. THIS MATERIAL EVENT CONTAINS A Less than Cat 3 LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | |
| ENS 52780 | 31 May 2017 16:45:00 | 10 CFR 35.3045(a)(1) | Medical Event - Patient Received Less Dose than Prescribed | On May 31, 2017, the licensee's gamma knife model 'C' failed during treatment delivery. The couch retracted from the treatment position at 1245 (EDT) due to a clutch malfunction. Three out of five shots were delivered to the single planned lesion. The prescribed volume received a dose of 15 Gy versus the prescribed 20 Gy. Due to uncertainty regarding repair, the fixation frame was removed from the patient's head. Repair was completed at 1845 (EDT)." A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | |
| ENS 45174 | 18 February 2008 16:00:00 | 10 CFR 35.3045(a)(1) | Medical Event Involving a Dose That Is Different than Prescribed | On February 18, 2008, an administrative error medical event occurred at our Leksell Gamma Knife facility which resulted in the total dose delivered differing from the written directive by more than 20%, but which agreed with the therapy that was intended and planned by the radiation oncologist authorized user (AU) and the neurosurgeon. This was discovered during the 2008 annual quality management review that was completed on June 24, 2009. On February 18, 2008, a stereotactic radiosurgery treatment plan was developed by the neurosurgeon, AU and authorized medical physicist (AMP) that satisfied the therapy intentions of the AU and neurosurgeon. Two of the three metastatic lesions that were discussed in advance at the neurosurgery tumor board meeting on February 13, 2008 by the neurosurgeon and AU were treated, the third being geometrically out of range of the gamma knife system. Specifically, the lesion locations selected at the tumor board meeting were right cerebellum, right occipital lobe and left temporal/parietal. The left temporal/parietal was out of range. The correct intended dose of 20 Gy to 50% isodose was planned and delivered on February 18. The AU and AMP specified both lesions on the Gamma Knife planning QA form which was signed by the AU, Neurosurgeon and AMP. The AU signed the plan and initialed every page including screenshots of the isodoses superimposed on the MRI images for both lesions. The plan included all of the information required in 10 CFR 35.40 (b)(3). Finally, the time out form was completed by the AU, neurosurgeon and AMP. The administrative error medical event is the result of the AU not writing a directive for treatment of the right occipital lesion. (The event occurred due to) lack of attention to administrative tasks. (The individual who received the administration had) no detrimental effect. Treatment was delivered as planned according to doctor's orders. The gamma knife quality management review will be done on the day of treatment prior to delivery by a second physicist using the form/checklist attached. This process is already in effect. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |