Event Notification Report for July 13, 2017
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
07/12/2017 - 07/13/2017
Part 21
Event Number: 52926
Rep Org: ELEKTA
Licensee: ELEKTA
Region: 1
City: ATLANTA State: GA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: DEBRA BENSEN
HQ OPS Officer: HOWIE CROUCH
Licensee: ELEKTA
Region: 1
City: ATLANTA State: GA
County:
License #:
Agreement: Y
Docket:
NRC Notified By: DEBRA BENSEN
HQ OPS Officer: HOWIE CROUCH
Notification Date: 08/25/2017
Notification Time: 11:47 [ET]
Event Date: 07/13/2017
Event Time: 00:00 [EDT]
Last Update Date: 08/25/2017
Notification Time: 11:47 [ET]
Event Date: 07/13/2017
Event Time: 00:00 [EDT]
Last Update Date: 08/25/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(d)(3)(i) - DEFECTS AND NONCOMPLIANCE
10 CFR Section:
21.21(d)(3)(i) - DEFECTS AND NONCOMPLIANCE
Person (Organization):
SILAS KENNEDY (R1DO)
EUGENE GUTHRIE (R2DO)
BILLY DICKSON (R3DO)
THOMAS FARNHOLTZ (R4DO)
PART 21 MATERIALS (EMAI)
SILAS KENNEDY (R1DO)
EUGENE GUTHRIE (R2DO)
BILLY DICKSON (R3DO)
THOMAS FARNHOLTZ (R4DO)
PART 21 MATERIALS (EMAI)
PART 21 NOTIFICATION - ONCENTRA SOFTWARE PROBLEM MAY CAUSE UNINTENDED STEP SIZE DURING BRACHYTHERAPY TREATMENT
On July 13, 2017, a user in France notified Elekta that they discovered a software issue during their Quality Assurance audit of Elekta's Oncentra Brachy software. Elekta investigated and determined a software issue exists in Oncentra software versions 4.5, 4.5.1, and 4.5.2.
On August 11, 2017, Elekta issued an important field safety notice (IFSN) worldwide.
The software issue will be resolved in the next issued version of the Oncentra software.
See related NRC event numbers 52922 and 52914.
Elekta point of contact: Debra Bensen, RSO, debbie.bensen@elekta.com or (770) 670-2518.
On July 13, 2017, a user in France notified Elekta that they discovered a software issue during their Quality Assurance audit of Elekta's Oncentra Brachy software. Elekta investigated and determined a software issue exists in Oncentra software versions 4.5, 4.5.1, and 4.5.2.
On August 11, 2017, Elekta issued an important field safety notice (IFSN) worldwide.
The software issue will be resolved in the next issued version of the Oncentra software.
See related NRC event numbers 52922 and 52914.
Elekta point of contact: Debra Bensen, RSO, debbie.bensen@elekta.com or (770) 670-2518.
Part 21
Event Number: 52852
Rep Org: CURTISS WRIGHT
Licensee: NOVA MACHINE PRODUCTS
Region: 3
City: MIDDLEBURG HEIGHTS State: OH
County:
License #:
Agreement: Y
Docket:
NRC Notified By: FRANK FURFARI
HQ OPS Officer: DONG HWA PARK
Licensee: NOVA MACHINE PRODUCTS
Region: 3
City: MIDDLEBURG HEIGHTS State: OH
County:
License #:
Agreement: Y
Docket:
NRC Notified By: FRANK FURFARI
HQ OPS Officer: DONG HWA PARK
Notification Date: 07/13/2017
Notification Time: 15:39 [ET]
Event Date: 07/13/2017
Event Time: 00:00 [EDT]
Last Update Date: 07/13/2017
Notification Time: 15:39 [ET]
Event Date: 07/13/2017
Event Time: 00:00 [EDT]
Last Update Date: 07/13/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21(d)(3)(i) - DEFECTS AND NONCOMPLIANCE
10 CFR Section:
21.21(d)(3)(i) - DEFECTS AND NONCOMPLIANCE
Person (Organization):
ANTHONY DIMITRIADIS (R1DO)
PART 21/50.55 REACTO (EMAI)
ANTHONY DIMITRIADIS (R1DO)
PART 21/50.55 REACTO (EMAI)
PART 21- HEX CAP SCREWS PRODUCED WITH PRE-EXISTING CRACKS
The following was submitted by the licensee via facsimile:
"This Part 21 initial notification is being submitted pursuant to the requirements of 10CFR21.21(d)(3)(i).
"Initial Notification for Hex Cap Screws produced from one heat of material - Nova Machine Products Fastener Part Numbers BPRT.008227.30, BPRT.008468.30, and BPRT.008342.30.
"This Part 21 initial notification addresses Nova Machine Products hex cap screws which contain pre-existing cracks as a result of a manufacturing process error (Forged blanks were rapidly cooled after forging instead of air cooled).
"The fasteners in question were all produced from one heat of material, which was used to produce one blank size, which was then used to produce the three hex cap screw part numbers stated above.
"Fasteners were only supplied to Exelon TMI and Exelon Peach Bottom and are isolated to one heat of material and one manufacturing run. Containment actions are already underway with Exelon and Nova Machine.
"Nova Machine and Exelon have been and continue to be in communication on this matter. This appears to be an isolated instance.
"If there are any questions pertaining to this communication, please contact Frank Furfari, Sr. Quality Assurance Manager at 216-898-8394."
The following was submitted by the licensee via facsimile:
"This Part 21 initial notification is being submitted pursuant to the requirements of 10CFR21.21(d)(3)(i).
"Initial Notification for Hex Cap Screws produced from one heat of material - Nova Machine Products Fastener Part Numbers BPRT.008227.30, BPRT.008468.30, and BPRT.008342.30.
"This Part 21 initial notification addresses Nova Machine Products hex cap screws which contain pre-existing cracks as a result of a manufacturing process error (Forged blanks were rapidly cooled after forging instead of air cooled).
"The fasteners in question were all produced from one heat of material, which was used to produce one blank size, which was then used to produce the three hex cap screw part numbers stated above.
"Fasteners were only supplied to Exelon TMI and Exelon Peach Bottom and are isolated to one heat of material and one manufacturing run. Containment actions are already underway with Exelon and Nova Machine.
"Nova Machine and Exelon have been and continue to be in communication on this matter. This appears to be an isolated instance.
"If there are any questions pertaining to this communication, please contact Frank Furfari, Sr. Quality Assurance Manager at 216-898-8394."
Agreement State
Event Number: 52858
Rep Org: ARIZONA RADIATION REGULATORY AGENCY
Licensee: GEOTEK INSITE, INC.
Region: 4
City: PHOENIX State: AZ
County:
License #: AZ 07-495
Agreement: Y
Docket:
NRC Notified By: BRIAN GORETZKI
HQ OPS Officer: VINCE KLCO
Licensee: GEOTEK INSITE, INC.
Region: 4
City: PHOENIX State: AZ
County:
License #: AZ 07-495
Agreement: Y
Docket:
NRC Notified By: BRIAN GORETZKI
HQ OPS Officer: VINCE KLCO
Notification Date: 07/14/2017
Notification Time: 11:13 [ET]
Event Date: 07/13/2017
Event Time: 00:00 [MST]
Last Update Date: 07/14/2017
Notification Time: 11:13 [ET]
Event Date: 07/13/2017
Event Time: 00:00 [MST]
Last Update Date: 07/14/2017
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
DAVID PROULX (R4DO)
NMSS_EVENTS_NOTIFICA (EMAI)
DAVID PROULX (R4DO)
NMSS_EVENTS_NOTIFICA (EMAI)
AGREEMENT STATE REPORT - DAMAGED SHUTTER
The following information was received from the State of Arizona via email:
"This First Notice constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received WITHOUT verification or evaluation, and is basically all that is known by the Agency [Arizona Radiation Regulatory Agency] Staff at this time.
"During an inspection of the licensee on July 13, 2017, an inspector found one portable gauge where the radiation source exposure shutter would not close when moved to the closed position. The inspector's dose measurement at contact with the device was approximately 100 mR/hr. The gauge is a Troxler model 3430, Serial Number 30302, containing 8 milliCuries of Cesium-137 and 40 milliCuries of Americium-241. The licensee has contacted a repair company to fix the gauge as soon as possible.
"The Agency is investigating the event.
"The Governor's office and U.S. NRC are being notified of this event. "
Arizona First Notice: 17-009
The following information was received from the State of Arizona via email:
"This First Notice constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received WITHOUT verification or evaluation, and is basically all that is known by the Agency [Arizona Radiation Regulatory Agency] Staff at this time.
"During an inspection of the licensee on July 13, 2017, an inspector found one portable gauge where the radiation source exposure shutter would not close when moved to the closed position. The inspector's dose measurement at contact with the device was approximately 100 mR/hr. The gauge is a Troxler model 3430, Serial Number 30302, containing 8 milliCuries of Cesium-137 and 40 milliCuries of Americium-241. The licensee has contacted a repair company to fix the gauge as soon as possible.
"The Agency is investigating the event.
"The Governor's office and U.S. NRC are being notified of this event. "
Arizona First Notice: 17-009