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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodePEA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
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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