TPLC - Total Product Life Cycle

• Device: system, applicator, radionuclide, remote-controlled
• Regulation Description: Remote controlled radionuclide applicator system.
• Product Code: JAQ
• Regulation Number: 892.5700
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALPHA-OMEGA SERVICES, INC.
	SUBSTANTIALLY EQUIVALENT	2
BRAXX BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUCLETRON B.V.
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	4
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	10

MDR Year	MDR Reports	MDR Events
2021	5	6
2022	5	5
2023	3	3
2024	1	1
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	2	2
Improper or Incorrect Procedure or Method	2	2
Break	1	1
Difficult to Remove	1	1
Positioning Failure	1	1
Use of Device Problem	1	2
Obstruction of Flow	1	1
Material Twisted/Bent	1	1
Application Program Problem: Dose Calculation Error	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Product Quality Problem	1	2
Inadequacy of Device Shape and/or Size	1	1
Detachment of Device or Device Component	1	1
Computer Software Problem	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6	6
Foreign Body In Patient	4	4
Insufficient Information	4	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Laceration(s)	1	1
Radiation Burn	1	2
Hemorrhage/Bleeding	1	1