TPLC - Total Product Life Cycle

show TPLC since

Device	light source, fiberoptic, routine
Product Code	FCW
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
NOVAPROBE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
OLIVE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
SUNOPTIC TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	185	185
Overheating of Device	165	165
Temperature Problem	98	98
Smoking	97	97
Circuit Failure	84	84
Device Emits Odor	76	76
Display or Visual Feedback Problem	62	62
Electrical /Electronic Property Problem	57	57
Thermal Decomposition of Device	54	54
Adverse Event Without Identified Device or Use Problem	42	42
No Display/Image	41	41
Melted	40	40
Failure to Power Up	37	37
Break	35	35
Power Problem	31	31
Poor Quality Image	27	27
Loss of Power	23	23
Fire	20	20
Detachment of Device or Device Component	20	20
Intermittent Continuity	19	19
Intermittent Loss of Power	17	17
Sparking	16	16
Use of Device Problem	15	15
Optical Problem	15	15
Mechanical Problem	12	12
Device Operates Differently Than Expected	11	11
Excessive Heating	10	10
Noise, Audible	10	10
Unexpected Shutdown	10	10
Computer Software Problem	8	8
Connection Problem	8	8
Electrical Shorting	8	8
Loose or Intermittent Connection	7	7
Device Contaminated During Manufacture or Shipping	7	7
Insufficient Information	7	7
Crack	6	6
No Device Output	6	6
Failure to Shut Off	6	6
Flare or Flash	5	5
Environmental Particulates	5	5
Device Dislodged or Dislocated	5	5
Electrical Power Problem	4	4
Energy Output Problem	4	4
Device Fell	4	4
Material Integrity Problem	4	4
Environmental Compatibility Problem	4	4
Appropriate Term/Code Not Available	4	4
Device Inoperable	3	3
Component Falling	3	3
Device Damaged Prior to Use	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	593	593
No Known Impact Or Consequence To Patient	237	237
No Consequences Or Impact To Patient	133	133
Insufficient Information	68	68
Burn(s)	64	64
No Patient Involvement	26	26
Burn, Thermal	17	17
Superficial (First Degree) Burn	15	15
Not Applicable	11	11
No Information	8	8
Injury	5	5
Partial thickness (Second Degree) Burn	4	4
No Code Available	3	3
Patient Problem/Medical Problem	2	2
Full thickness (Third Degree) Burn	2	2
Electric Shock	1	1
Abrasion	1	1
Scarring	1	1
Foreign Body In Patient	1	1
Erythema	1	1
Swelling	1	1
Shock	1	1
Unspecified Tissue Injury	1	1
Discharge	1	1
Skin Burning Sensation	1	1