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
CIVATECH ONCOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
GT MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
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	59	59
Inaccurate Information	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Inadequate Instructions for Healthcare Professional	5	5
Device Contamination with Chemical or Other Material	5	5
Positioning Failure	5	5
Mechanical Jam	4	4
Component Missing	4	4
Fitting Problem	3	3
Break	3	3
Output Problem	3	3
Lack of Maintenance Documentation or Guidelines	3	3
Insufficient Information	3	3
Missing Information	3	3
Material Twisted/Bent	3	3
Labelling, Instructions for Use or Training Problem	3	3
Failure to Discharge	2	2
Device Markings/Labelling Problem	2	2
Wrong Label	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Material Fragmentation	2	2
Unintended Ejection	2	2
Tear, Rip or Hole in Device Packaging	2	2
Packaging Problem	2	2
Appropriate Term/Code Not Available	1	1
Failure to Advance	1	1
Component Misassembled	1	1
Installation-Related Problem	1	1
Detachment of Device or Device Component	1	1
Material Deformation	1	1
Difficult to Insert	1	1
Microbial Contamination of Device	1	1
Contamination	1	1
Radiation Overexposure	1	1
Positioning Problem	1	1
Defective Device	1	1
Unsealed Device Packaging	1	1
Unclear Information	1	1
Patient-Device Incompatibility	1	1
Accessory Incompatible	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	104	104
No Known Impact Or Consequence To Patient	12	12
No Consequences Or Impact To Patient	10	10
No Patient Involvement	8	8
Post Operative Wound Infection	6	6
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
Arthralgia	1	1
Death	1	1
Urinary Incontinence	1	1
Inflammation	1	1
Incontinence	1	1
Urinary Retention	1	1
Dyspnea	1	1
Pain	1	1
Myocardial Infarction	1	1
Ambulation Difficulties	1	1