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TPLC
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Device
endoscope, accessories, image post-processing for color enhancement
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
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
90
90
Optical Problem
47
47
Unintended Movement
38
38
Erratic or Intermittent Display
38
38
Break
37
37
Product Quality Problem
34
34
Image Display Error/Artifact
29
29
Poor Quality Image
22
22
Circuit Failure
18
18
Display or Visual Feedback Problem
13
13
Data Problem
8
8
Unintended System Motion
8
8
Failure to Power Up
6
6
Device Markings/Labelling Problem
6
6
Optical Distortion
6
6
Optical Obstruction
5
5
Patient Data Problem
5
5
Optical Discoloration
5
5
Computer Software Problem
5
5
Loose or Intermittent Connection
5
5
Electrical /Electronic Property Problem
4
4
Fracture
3
3
Fluid/Blood Leak
3
3
Intermittent Loss of Power
3
3
Positioning Problem
3
3
Unintended Power Up
3
3
Communication or Transmission Problem
3
3
Connection Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Damaged by Another Device
2
2
Application Program Freezes, Becomes Nonfunctional
2
2
Power Problem
2
2
Display Difficult to Read
2
2
Unintended Electrical Shock
2
2
Fogging
2
2
Material Split, Cut or Torn
2
2
Unstable
2
2
Device Reprocessing Problem
1
1
Application Network Problem
1
1
Activation Failure
1
1
Ambient Noise Problem
1
1
Decreased Sensitivity
1
1
Device Emits Odor
1
1
No Apparent Adverse Event
1
1
Misconnection
1
1
Device Displays Incorrect Message
1
1
Obstruction of Flow
1
1
Degraded
1
1
Incomplete or Inadequate Connection
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
370
370
No Consequences Or Impact To Patient
24
24
Insufficient Information
16
16
No Known Impact Or Consequence To Patient
7
7
Melena
2
2
Electric Shock
2
2
Burn(s)
2
2
Vomiting
2
2
Pain
2
2
Undesired Nerve Stimulation
2
2
No Information
1
1
No Patient Involvement
1
1
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