TPLC - Total Product Life Cycle

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Device	led light source
Definition	Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Product Code	NTN
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
FIBEROPTICS TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAQUET SAS
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	2
OPTIM, INC.
	SUBSTANTIALLY EQUIVALENT	1
QUEST MEDICAL IMAGING
	SUBSTANTIALLY EQUIVALENT	1
SCHOELLY IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOPRO
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	99	99
Optical Problem	86	86
Poor Quality Image	76	76
Unexpected Shutdown	16	16
Adverse Event Without Identified Device or Use Problem	9	9
Connection Problem	9	9
Failure to Power Up	7	7
Overheating of Device	4	4
Use of Device Problem	3	3
Human-Device Interface Problem	3	3
Excessive Heating	2	2
Improper or Incorrect Procedure or Method	2	2
Smoking	2	2
Thermal Decomposition of Device	2	2
Computer Software Problem	1	1
Electrical /Electronic Property Problem	1	1
Fire	1	1
Inadequate Instructions for Healthcare Professional	1	1
Material Separation	1	1
Inadequate or Insufficient Training	1	1
Defective Device	1	1
Detachment of Device or Device Component	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Inadequate Lighting	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	124	124
No Consequences Or Impact To Patient	55	55
Burn(s)	6	6
Superficial (First Degree) Burn	4	4
No Known Impact Or Consequence To Patient	2	2
No Information	1	1
No Code Available	1	1
Blister	1	1
Insufficient Information	1	1
Bradycardia	1	1
Burn, Thermal	1	1