The following information was provided by the licensee via phone and email:
On November 19, 2025, Pd-103 seeds were retrieved from secure storage and brought directly to the operating room in accordance with established protocol. Pre-procedure planning; including review of the treatment plan, seed mapping, and completion of the written directive; was completed prior to patient arrival.
The patient was brought to the operating room at 1145 [EST]. A standardized time-out was performed to confirm correct patient, procedure, antibiotic administration, fire safety considerations, and seed verification. The patient was anesthetized and positioned, and the procedure began at 1151 and ended at 1207. An active, collaborative seed count was maintained throughout the case.
During the debriefing phase, the radiation oncologist authorized user, surgical technologist, and nursing staff verbally confirmed the number of seeds implanted, the number of needles used, and the remaining seeds to be returned to storage. The patient was then transferred to recovery.
During post-procedure room turnover, the surgical technologist reported difficulty removing the final seed cartridge from the applicator. She attempted to remove it by unscrewing the cartridge holder but was unsuccessful. After reassembling the device, she handed it to the radiation oncologist, who was able to partially remove the cartridge. The portion of the cartridge that remained connected to the applicator is presumed to have contained the unused seeds. The applicator was then sent to the central processing department (CPD) for sterilization with part of the cartridge still lodged inside. It was processed through CPD as routine.
Based on the investigation, it is presumed that during the sterilization process the [eight] remaining Pd-103 seeds became dislodged from the cartridge assembly. Once separated, the seeds would have entered the wastewater stream and been carried into the sanitary sewer system, resulting in their unintentional disposal.
Below are the calculations documenting the classification of reporting requirements.
Sealed source certificate Pd-103 certified the following:
Activity range: 2.59 - 2.80 mCi
Maximum activity: 2.80 mCi x 8 seeds = 22.4 mCi
Regulations for immediate reporting - Pd-103 100 (Part 20 Appendix C) x1000=100000 = 100 mCi
Total activity lost - 22.4 mCi - not reportable under 20.2201(a)(i)
Regulations for report within 30 days - Pd-103 100 (Part 20 Appendix C) x10=1000 = 1 mCi
Total activity lost - 22.4 mCi - reportable under 20.2201(a)(ii)
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