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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
ENDOCHOICE INC.
SUBSTANTIALLY EQUIVALENT
1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
SUBSTANTIALLY EQUIVALENT
1
PENTAX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
PENTAX OF AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
5
MDR Year
MDR Reports
MDR Events
2015
2
2
2016
3
3
2017
1
1
2018
38
38
2019
30
30
2020
8
8
2021
201
201
2022
66
66
2023
78
78
2024
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
88
88
Image Display Error/Artifact
58
58
Optical Problem
47
47
Unintended Movement
38
38
Break
35
35
Product Quality Problem
33
33
Erratic or Intermittent Display
31
31
Poor Quality Image
25
25
Circuit Failure
18
18
Display or Visual Feedback Problem
13
13
Unintended System Motion
8
8
Data Problem
8
8
Optical Distortion
6
6
Device Markings/Labelling Problem
6
6
Failure to Power Up
6
6
Loose or Intermittent Connection
5
5
Computer Software Problem
5
5
Optical Discoloration
5
5
Patient Data Problem
5
5
Positioning Problem
4
4
Electrical /Electronic Property Problem
4
4
Fluid/Blood Leak
3
3
Fogging
3
3
Fracture
3
3
Unintended Power Up
3
3
Leak/Splash
3
3
Optical Obstruction
3
3
Communication or Transmission Problem
3
3
Intermittent Loss of Power
3
3
Unintended Electrical Shock
2
2
Material Split, Cut or Torn
2
2
Application Program Freezes, Becomes Nonfunctional
2
2
Connection Problem
2
2
Device Damaged by Another Device
2
2
Output Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Power Problem
2
2
Unstable
2
2
Sparking
2
2
Display Difficult to Read
2
2
Degraded
1
1
Device Reprocessing Problem
1
1
Collapse
1
1
Mechanical Problem
1
1
Misconnection
1
1
Moisture Damage
1
1
Ambient Noise Problem
1
1
Application Network Problem
1
1
Blocked Connection
1
1
Device Issue
1
1
Obstruction of Flow
1
1
Decreased Sensitivity
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Device Emits Odor
1
1
Energy Output Problem
1
1
Unauthorized Access to Computer System
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Device Operates Differently Than Expected
1
1
Device Contamination With Biological Material
1
1
Failure to Transmit Record
1
1
Self-Activation or Keying
1
1
Incomplete or Inadequate Connection
1
1
Failure to Clean Adequately
1
1
Air/Gas in Device
1
1
Unexpected Shutdown
1
1
Excessive Heating
1
1
Activation Failure
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
349
349
No Consequences Or Impact To Patient
56
56
No Known Impact Or Consequence To Patient
17
17
Insufficient Information
16
16
No Patient Involvement
4
4
Melena
2
2
Electric Shock
2
2
Burn(s)
2
2
Undesired Nerve Stimulation
2
2
Pain
2
2
Vomiting
2
2
No Information
1
1
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