TPLC - Total Product Life Cycle

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Device	source, brachytherapy, radionuclide
Regulation Description	Radionuclide brachytherapy source.
Product Code	KXK
Regulation Number	892.5730
Device Class	2

Premarket Reviews
Manufacturer	Decision
GT MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
ISOAID, LLC
	SUBSTANTIALLY EQUIVALENT	1
ISORAY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LV LIBERTY VISION CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
RADIANCE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	61	61
Inaccurate Information	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Positioning Failure	5	5
Device Contamination with Chemical or Other Material	4	4
Mechanical Jam	4	4
Fitting Problem	3	3
Output Problem	3	4
Insufficient Information	3	3
Component Missing	3	3
Material Twisted/Bent	3	3
Missing Information	3	3
Labelling, Instructions for Use or Training Problem	3	3
Lack of Maintenance Documentation or Guidelines	3	3
Break	2	2
Device Markings/Labelling Problem	2	2
Unclear Information	2	2
Wrong Label	2	2
Material Integrity Problem	2	2
Inadequate Instructions for Healthcare Professional	2	2
Material Fragmentation	2	2
Unintended Ejection	2	2
Packaging Problem	2	2
Inadequate Instructions for Non-Healthcare Professional	1	1
Positioning Problem	1	1
Defective Device	1	1
Unsealed Device Packaging	1	1
Radiation Overexposure	1	1
Microbial Contamination of Device	1	1
Difficult to Insert	1	2
Material Deformation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Component Misassembled	1	1
Appropriate Term/Code Not Available	1	1
Failure to Advance	1	1
Failure to Discharge	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	108	109
Post Operative Wound Infection	6	6
No Consequences Or Impact To Patient	6	6
No Known Impact Or Consequence To Patient	5	5
No Patient Involvement	4	4
Necrosis	3	3
Unintended Radiation Exposure	3	3
Needle Stick/Puncture	2	2
Insufficient Information	2	2
Cerebral Edema	2	2
Unspecified Infection	1	1
Death	1	1
Fatigue	1	1
Urinary Incontinence	1	1
Malaise	1	1
Incontinence	1	1
Confusion/ Disorientation	1	1
Urinary Retention	1	1
Myocardial Infarction	1	1