ENS 46082
ENS Event | |
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05:00 Jul 9, 2010 | |
Title | Agreement State - Brachytherapy Treatment Dose Delivered Differs from Prescribed |
Event Description | The following was received via fax from the State of Wisconsin:
On July 8, 2010, the licensee's Radiation Safety Officer (RSO) reported the preliminary identification of six medical events involving permanent implants of I-125 for prostate brachytherapy where the total dose delivered differs from the prescribed dose by 20% or more. During recent routine inspection, DHS [Department of Health Services] inspectors determined that the licensee was not reviewing prostate brachytherapy cases against the medical event criteria. The licensee is currently evaluating all 269 prostate implants performed since August 2003. This review is ongoing and will include an assessment of whether any implants involved doses to an organ or tissue above 0.50 Sv and 50% more than the expected dose. The licensee is in the process of notifying the affected patients and referring physicians. The reported medical events involve two locations of use. One facility identified three under doses (74.8%, 75.2%, and 76.5%) and one overdose (121.4%). The second facility identified one under dose (78.2%) and one overdose (121.0%). DHS inspectors are investigating these medical events and will send a special inspection team following completion of the licensee's review Event Report No.: WI100012 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.
This is an update to Event Notification 46082. On July 20, 2010, the licensee's Radiation Safety Officer reported the identification of three additional medical events involving permanent implants of I-125 for prostate brachytherapy where the doses to all organ or tissue is above 0.50 Sv and 50% more than the expected dose. The licensee increased the cases reviewed to 275 prostate brachytherapy cases against the medical event criteria. The licensee is in the process of notifying the affected patients and referring physicians. The three additional medical events were overdoses to the urethra (159.7%, 161.3% and 151.6%). DHS inspectors are investigating these medical events and will send a special inspection team. Notified R3DO (Stone) and FSME (Ries). |
Where | |
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Marshfield Clinic Marshfield, Wisconsin (NRC Region 3) | |
License number: | 141-1162-01 |
Organization: | Wisconsin Radiation Protection |
Reporting | |
Agreement State | |
Time - Person (Reporting Time:+7.83 h0.326 days <br />0.0466 weeks <br />0.0107 months <br />) | |
Opened: | Megan Shober 12:50 Jul 9, 2010 |
NRC Officer: | Charles Teal |
Last Updated: | Jul 20, 2010 |
46082 - NRC Website | |
Marshfield Clinic with Agreement State | |
WEEKMONTHYEARENS 560822022-08-10T05:00:00010 August 2022 05:00:00
[Table view]Agreement State Lost Y-90 Microspheres ENS 508232015-02-13T06:00:00013 February 2015 06:00:00 Agreement State Agreement State Report - Gamma Knife Unit Failed to Function as Designed ENS 462492010-09-09T05:00:0009 September 2010 05:00:00 Agreement State Agreement State Report - Delivered Dose Is Different from the Prescribed Dose ENS 460822010-07-09T05:00:0009 July 2010 05:00:00 Agreement State Agreement State - Brachytherapy Treatment Dose Delivered Differs from Prescribed ENS 414202005-02-16T06:00:00016 February 2005 06:00:00 Agreement State Agreement State Medical Event 2022-08-10T05:00:00 | |