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TPLC
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show TPLC since
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2025
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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
MDR Year
MDR Reports
MDR Events
2019
18
18
2020
114
114
2021
149
149
2022
158
158
2023
200
200
2024
296
296
2025
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
198
198
Electrical /Electronic Property Problem
185
185
Failure to Power Up
80
80
No Device Output
72
72
Poor Quality Image
55
55
Erratic or Intermittent Display
48
48
Break
44
44
No Visual Prompts/Feedback
40
40
Display or Visual Feedback Problem
37
37
Defective Device
31
31
Output Problem
27
27
Communication or Transmission Problem
22
22
Optical Problem
19
19
Power Problem
19
19
Thermal Decomposition of Device
13
13
Connection Problem
11
11
Overheating of Device
10
10
Activation Failure
10
10
Noise, Audible
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Mechanical Problem
8
8
Flare or Flash
7
7
Loose or Intermittent Connection
6
6
Energy Output Problem
6
6
Defective Component
6
6
Application Program Problem
5
5
Image Display Error/Artifact
5
5
Loss of Power
5
5
Display Difficult to Read
5
5
Signal Artifact/Noise
4
4
Unexpected Shutdown
4
4
Intermittent Loss of Power
4
4
Electrical Power Problem
3
3
Excessive Heating
3
3
Smoking
3
3
Key or Button Unresponsive/not Working
3
3
Off-Label Use
2
2
Temperature Problem
2
2
Corroded
2
2
Defective Alarm
2
2
Sparking
2
2
Blocked Connection
2
2
Material Integrity Problem
2
2
Unintended Power Up
2
2
Operating System Becomes Nonfunctional
1
1
Degraded
1
1
Misconnection
1
1
Optical Obstruction
1
1
Infusion or Flow Problem
1
1
Melted
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
800
800
No Consequences Or Impact To Patient
154
154
No Known Impact Or Consequence To Patient
11
11
Burn(s)
4
4
No Code Available
2
2
Partial thickness (Second Degree) Burn
2
2
Blister
1
1
No Information
1
1
Hemorrhage/Bleeding
1
1
Insufficient Information
1
1
Eye Injury
1
1
Shock
1
1
Burn, Thermal
1
1
Injury
1
1
No Patient Involvement
1
1
Death
1
1
Superficial (First Degree) Burn
1
1
Unspecified Tissue Injury
1
1
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