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TPLC
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Device
endoscope, accessories, image post-processing for color enhancement
Regulation Description
Endoscope and accessories.
Definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Product Code
PEA
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
PENTAX OF AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
30
30
2020
8
8
2021
201
201
2022
66
66
2023
78
78
2024
103
103
2025
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
114
114
Optical Problem
48
48
Erratic or Intermittent Display
47
47
Unintended Movement
46
46
Break
44
44
Product Quality Problem
34
34
Poor Quality Image
30
30
Image Display Error/Artifact
29
29
Circuit Failure
18
18
Display or Visual Feedback Problem
13
13
Overheating of Device
10
10
Data Problem
9
9
Unintended System Motion
8
8
Failure to Power Up
6
6
Fluid/Blood Leak
6
6
Optical Obstruction
6
6
Optical Distortion
6
6
Device Markings/Labelling Problem
6
6
Optical Discoloration
5
5
Obstruction of Flow
5
5
Patient Data Problem
5
5
Loose or Intermittent Connection
5
5
Computer Software Problem
5
5
Electrical /Electronic Property Problem
4
4
Intermittent Loss of Power
3
3
Suction Problem
3
3
Communication or Transmission Problem
3
3
Unintended Power Up
3
3
Fracture
3
3
Positioning Problem
3
3
Connection Problem
3
3
Display Difficult to Read
2
2
Material Split, Cut or Torn
2
2
Device Damaged by Another Device
2
2
Application Program Freezes, Becomes Nonfunctional
2
2
Power Problem
2
2
Fogging
2
2
Unintended Electrical Shock
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Unstable
2
2
Electrical Overstress
2
2
Sparking
1
1
Self-Activation or Keying
1
1
Energy Output Problem
1
1
Mechanical Problem
1
1
Application Network Problem
1
1
Device Displays Incorrect Message
1
1
Excessive Heating
1
1
Defective Device
1
1
Unexpected Shutdown
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
443
443
No Consequences Or Impact To Patient
24
24
Insufficient Information
16
16
No Known Impact Or Consequence To Patient
7
7
Melena
2
2
Undesired Nerve Stimulation
2
2
Vomiting
2
2
Burn(s)
2
2
Electric Shock
2
2
Pain
2
2
No Patient Involvement
1
1
No Information
1
1
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