Event Notification Report for November 01, 2021
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
10/31/2021 - 11/01/2021
Agreement State
Event Number: 56041
Rep Org: SC Dept of Health & Env Control
Licensee: Prisma Health Richland Hospital
Region: 1
City: Columbia State: SC
County:
License #: 586
Agreement: Y
Docket:
NRC Notified By: Adam Gause
HQ OPS Officer: Karen Cotton-Gross
Licensee: Prisma Health Richland Hospital
Region: 1
City: Columbia State: SC
County:
License #: 586
Agreement: Y
Docket:
NRC Notified By: Adam Gause
HQ OPS Officer: Karen Cotton-Gross
Notification Date: 08/11/2022
Notification Time: 09:15 [ET]
Event Date: 11/01/2021
Event Time: 00:00 [EDT]
Last Update Date: 11/22/2022
Notification Time: 09:15 [ET]
Event Date: 11/01/2021
Event Time: 00:00 [EDT]
Last Update Date: 11/22/2022
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Dimitriadis, Anthony (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Dimitriadis, Anthony (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
EN Revision Imported Date: 11/29/2022
EN Revision Text: AGREEMENT STATE REPORT - GAMMA KNIFE MALFUNCTION
The following information was provided by South Carolina Department of Health & Environmental Control via email:
"The South Carolina Department of Health and Environmental Control was notified on 08/10/2022, during a follow-up of a routine inspection, that a Leksell Gamma Knife Perfexion gamma stereotactic radiosurgery unit had failed to function as designed. The licensee [Prisma Health Richland Hospital] is reporting that during routine maintenance that was conducted by the manufacturer on 11/01/2021, it was discovered that a sector was dragging and not transferring smoothly. The licensee is reporting that one of the sealed sources had slipped less than 1/8 inch within one of the source cavities of the Leksell Gamma Knife Perfexion unit. The sealed source is a Co-60 Elekta Model 43685 medical teletherapy source, with an estimated activity between 20-22 curies. The licensee is reporting the unit was repaired and source reseated on 11/05/2021. The licensee is reporting no overexposures to workers, patients, or members of the public. All sealed sources were leak tested on 11/05/2021 and results indicated that no sources were leaking. This event is under investigation by the South Carolina Department of Health and Environmental Control."
* * * UPDATE ON 9/7/2022 AT 1158 EDT FROM ADAM GAUSE TO MICHAEL BLOODGOOD * * *
The following information was provided by South Carolina Department of Health & Environmental Control via email:
"The licensee has submitted a 30-day written report. The Co-60 Elekta Model 43685 medical teletherapy source serial number is NIW098 with an estimated activity of 20.6 Ci (0.7622 TBq) at the time of the event. On 11/05/2021, the manufacturer and service representative identified the bushing containing the source had slipped slightly from its sleeve. The bushing was visually inspected via remote camera and showed no damage. The bushing and source was reseated into its sleeve on 11/05/2021. No patients were treated between 11/1/2021-11/10/2021. The licensee is reporting no overexposures or medical events. The licensee performed areas surveys (using a Fluke 451PYR, calibrated 04/08/21) on 11/03/21 and 11/05/21, records indicated dose rate readings that were consistent with the radiation levels in the sealed source and device registry for the Perfexion unit. The licensee also performed area contamination surveys/wipes (using a Capintec Captrac, calibrated 10/18/21) on 11/03/21 and 11/05/21, records indicated contamination levels below the licensee's removable contamination trigger limits. This event is still under investigation by the South Carolina Department of Health and Environmental Control."
Notified R1DO (Defrancisco) and NMSS Event Notification via email.
* * * UPDATE ON 11/22/2022 AT 1501 EST FROM ADAM GAUSE TO IAN HOWARD * * *
The following update was provided by the state of South Carolina via email:
"The manufacturer (Elekta, Inc.) submitted a report dated 10/14/22. The manufacturer's estimate of the effect on the dose rate is a reduction of about 0.3 percent for the 4 mm collimator with one loose bushing in the worst angle. The manufacturer's estimate of the effect on the delivered dose was 1.5 mGy less than planned. The licensee reported the typical patient dose range is 32-85 Gy. The manufacturer performed a root cause analysis in the report dated 10/14/22. The manufacturer determined that when pushing the bushing into the sleeve, the bushing can be slightly misaligned with the sleeve making it stick without the spring being properly activated. Later the bushing can come loose due to vibrations. The manufacturer determined this is what is likely to have happened here.
"The licensee's corrective actions included determining the root cause of the event, reseating the bushing and lubricating all sectors, determining no other bushings were loose/unseated, performing acceptance testing prior to treatment of the first patient after event, and having future source loadings confirm all source bushings are properly seated prior to turning the unit over for acceptance testing. The licensee did not identify any other instances where a source/bushing slippage had occurred. This event/investigation is closed."
Notified R1DO (Carfang) and NMSS Events Notification email group.
EN Revision Text: AGREEMENT STATE REPORT - GAMMA KNIFE MALFUNCTION
The following information was provided by South Carolina Department of Health & Environmental Control via email:
"The South Carolina Department of Health and Environmental Control was notified on 08/10/2022, during a follow-up of a routine inspection, that a Leksell Gamma Knife Perfexion gamma stereotactic radiosurgery unit had failed to function as designed. The licensee [Prisma Health Richland Hospital] is reporting that during routine maintenance that was conducted by the manufacturer on 11/01/2021, it was discovered that a sector was dragging and not transferring smoothly. The licensee is reporting that one of the sealed sources had slipped less than 1/8 inch within one of the source cavities of the Leksell Gamma Knife Perfexion unit. The sealed source is a Co-60 Elekta Model 43685 medical teletherapy source, with an estimated activity between 20-22 curies. The licensee is reporting the unit was repaired and source reseated on 11/05/2021. The licensee is reporting no overexposures to workers, patients, or members of the public. All sealed sources were leak tested on 11/05/2021 and results indicated that no sources were leaking. This event is under investigation by the South Carolina Department of Health and Environmental Control."
* * * UPDATE ON 9/7/2022 AT 1158 EDT FROM ADAM GAUSE TO MICHAEL BLOODGOOD * * *
The following information was provided by South Carolina Department of Health & Environmental Control via email:
"The licensee has submitted a 30-day written report. The Co-60 Elekta Model 43685 medical teletherapy source serial number is NIW098 with an estimated activity of 20.6 Ci (0.7622 TBq) at the time of the event. On 11/05/2021, the manufacturer and service representative identified the bushing containing the source had slipped slightly from its sleeve. The bushing was visually inspected via remote camera and showed no damage. The bushing and source was reseated into its sleeve on 11/05/2021. No patients were treated between 11/1/2021-11/10/2021. The licensee is reporting no overexposures or medical events. The licensee performed areas surveys (using a Fluke 451PYR, calibrated 04/08/21) on 11/03/21 and 11/05/21, records indicated dose rate readings that were consistent with the radiation levels in the sealed source and device registry for the Perfexion unit. The licensee also performed area contamination surveys/wipes (using a Capintec Captrac, calibrated 10/18/21) on 11/03/21 and 11/05/21, records indicated contamination levels below the licensee's removable contamination trigger limits. This event is still under investigation by the South Carolina Department of Health and Environmental Control."
Notified R1DO (Defrancisco) and NMSS Event Notification via email.
* * * UPDATE ON 11/22/2022 AT 1501 EST FROM ADAM GAUSE TO IAN HOWARD * * *
The following update was provided by the state of South Carolina via email:
"The manufacturer (Elekta, Inc.) submitted a report dated 10/14/22. The manufacturer's estimate of the effect on the dose rate is a reduction of about 0.3 percent for the 4 mm collimator with one loose bushing in the worst angle. The manufacturer's estimate of the effect on the delivered dose was 1.5 mGy less than planned. The licensee reported the typical patient dose range is 32-85 Gy. The manufacturer performed a root cause analysis in the report dated 10/14/22. The manufacturer determined that when pushing the bushing into the sleeve, the bushing can be slightly misaligned with the sleeve making it stick without the spring being properly activated. Later the bushing can come loose due to vibrations. The manufacturer determined this is what is likely to have happened here.
"The licensee's corrective actions included determining the root cause of the event, reseating the bushing and lubricating all sectors, determining no other bushings were loose/unseated, performing acceptance testing prior to treatment of the first patient after event, and having future source loadings confirm all source bushings are properly seated prior to turning the unit over for acceptance testing. The licensee did not identify any other instances where a source/bushing slippage had occurred. This event/investigation is closed."
Notified R1DO (Carfang) and NMSS Events Notification email group.
Agreement State
Event Number: 55553
Rep Org: Arizona Dept of Health Services
Licensee: Honor Health dba Deer Medical Center
Region: 4
City: Phoenix State: AZ
County:
License #: 07-311
Agreement: Y
Docket:
NRC Notified By: Brian Goretzki
HQ OPS Officer: Thomas Kendzia
Licensee: Honor Health dba Deer Medical Center
Region: 4
City: Phoenix State: AZ
County:
License #: 07-311
Agreement: Y
Docket:
NRC Notified By: Brian Goretzki
HQ OPS Officer: Thomas Kendzia
Notification Date: 11/02/2021
Notification Time: 16:19 [ET]
Event Date: 11/01/2021
Event Time: 00:00 [MST]
Last Update Date: 11/02/2021
Notification Time: 16:19 [ET]
Event Date: 11/01/2021
Event Time: 00:00 [MST]
Last Update Date: 11/02/2021
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Kozal, Jason (R4)
CNSNS (Mexico), - (EMAIL)) (EMAIL)
ILTAB, (EMAIL)
NMSS_Events_Notification, (EMAIL)
Kozal, Jason (R4)
CNSNS (Mexico), - (EMAIL)) (EMAIL)
ILTAB, (EMAIL)
NMSS_Events_Notification, (EMAIL)
EN Revision Imported Date: 12/2/2021
EN Revision Text: AGREEMENT STATE REPORT - MISSING I-125 SEED
The following information was received from the Arizona Department of Health Services (the Department) via email:
"On November 2, 2021, the Department was notified by the licensee of one missing I-125 radioactive seed for breast tumor localization. According to the licensee, two IsoAid Advantage I-125 breast localization seeds were removed by surgery on October 29, 2021 and were verified to be included in the specimen. The specimen with the seeds was delivered to pathology on the afternoon of October 29, 2021. The seeds were not removed from the specimen until November 1, 2021 by pathology. At this time, pathology was only able to locate one of the I-125 seeds. Nuclear Medicine performed surveys of pathology, pathology staff, the operating room and hallways leading from surgery to pathology. The licensee was unsuccessful in locating the one missing I-125 seed. [The missing I-125 seed was between 0.3 and 0.4 microcuries.] The Department has requested additional information and continues to investigate the event.
"Additional information will be provided as it is received in accordance with SA-300."
Arizona Incident No: 21-008
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
EN Revision Text: AGREEMENT STATE REPORT - MISSING I-125 SEED
The following information was received from the Arizona Department of Health Services (the Department) via email:
"On November 2, 2021, the Department was notified by the licensee of one missing I-125 radioactive seed for breast tumor localization. According to the licensee, two IsoAid Advantage I-125 breast localization seeds were removed by surgery on October 29, 2021 and were verified to be included in the specimen. The specimen with the seeds was delivered to pathology on the afternoon of October 29, 2021. The seeds were not removed from the specimen until November 1, 2021 by pathology. At this time, pathology was only able to locate one of the I-125 seeds. Nuclear Medicine performed surveys of pathology, pathology staff, the operating room and hallways leading from surgery to pathology. The licensee was unsuccessful in locating the one missing I-125 seed. [The missing I-125 seed was between 0.3 and 0.4 microcuries.] The Department has requested additional information and continues to investigate the event.
"Additional information will be provided as it is received in accordance with SA-300."
Arizona Incident No: 21-008
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