TPLC - Total Product Life Cycle

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Device	light source, endoscope, xenon arc
Regulation Description	Endoscope and accessories.
Product Code	GCT
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	326	326
Electrical /Electronic Property Problem	149	149
No Device Output	100	100
Poor Quality Image	94	94
Erratic or Intermittent Display	84	84
Failure to Power Up	73	73
Output Problem	47	47
Activation Failure	47	47
No Visual Prompts/Feedback	46	46
Display or Visual Feedback Problem	42	42
Break	37	37
Communication or Transmission Problem	33	33
Connection Problem	19	19
Power Problem	19	19
Optical Problem	19	19
Defective Device	17	17
Thermal Decomposition of Device	13	13
Activation Problem	12	12
Overheating of Device	11	11
Flare or Flash	10	10
Noise, Audible	9	9
Loose or Intermittent Connection	9	9
Unexpected Shutdown	8	8
Mechanical Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	8
Defective Component	7	7
Intermittent Loss of Power	6	6
Loss of Power	6	6
Energy Output Problem	6	7
Key or Button Unresponsive/not Working	6	6
Corroded	5	5
Excessive Heating	5	5
Signal Artifact/Noise	4	4
Material Integrity Problem	4	4
Output below Specifications	4	4
Detachment of Device or Device Component	4	4
Degraded	3	3
Incomplete or Inadequate Connection	3	3
Device Alarm System	3	3
Electrical Power Problem	3	3
Blocked Connection	3	3
Display Difficult to Read	3	3
Material Deformation	3	3
Image Display Error/Artifact	3	3
Circuit Failure	2	2
Sparking	2	2
Self-Activation or Keying	2	2
Off-Label Use	2	2
Complete Loss of Power	2	2
Melted	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1192	1192
No Consequences Or Impact To Patient	41	41
Burn(s)	4	4
Insufficient Information	2	2
No Information	1	1
Blister	1	1
Eye Injury	1	2
Unspecified Tissue Injury	1	1
Partial thickness (Second Degree) Burn	1	1
Hemorrhage/Bleeding	1	1