TPLC - Total Product Life Cycle

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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
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NUCLETRON BV
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
VARIAN MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	2
VARIAN MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	3
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6	6
Use of Device Problem	2	2
Material Twisted/Bent	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Crack	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Difficult to Remove	1	1
Positioning Failure	1	1
Obstruction of Flow	1	1
Application Program Problem: Dose Calculation Error	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
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
Connection Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7	7
Foreign Body In Patient	7	7
Insufficient Information	6	6
No Known Impact Or Consequence To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Oversedation	1	1
Laceration(s)	1	1
Radiation Burn	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Nucletron BV	II	Jan-02-2020