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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
image, illumination, fiberoptic, for endoscope
Product Code
FFS
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
19
19
2019
17
17
2020
56
56
2021
57
57
2022
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
52
52
Overheating of Device
49
49
Protective Measures Problem
16
16
Unexpected Shutdown
14
14
Insufficient Information
8
8
Power Problem
8
8
Loss of Power
4
4
Adverse Event Without Identified Device or Use Problem
2
2
No Apparent Adverse Event
2
2
Noise, Audible
2
2
Defective Component
2
2
Break
2
2
Thermal Decomposition of Device
2
2
No Display/Image
2
2
Electrical /Electronic Property Problem
1
1
Fire
1
1
Image Display Error/Artifact
1
1
Melted
1
1
Poor Quality Image
1
1
Device Emits Odor
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
Device Operates Differently Than Expected
1
1
Electrical Power Problem
1
1
Electrical Shorting
1
1
Inadequate Lighting
1
1
Smoking
1
1
Device Inoperable
1
1
Use of Device Problem
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Optical Obstruction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
83
83
No Known Impact Or Consequence To Patient
35
35
No Patient Involvement
33
33
Full thickness (Third Degree) Burn
3
3
No Information
3
3
No Consequences Or Impact To Patient
2
2
Blurred Vision
1
1
No Code Available
1
1
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