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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
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
Erratic or Intermittent Display 38 38
Unintended Movement 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
Device Markings/Labelling Problem 6 6
Optical Distortion 6 6
Failure to Power Up 6 6
Loose or Intermittent Connection 5 5
Computer Software Problem 5 5
Optical Obstruction 5 5
Patient Data Problem 5 5
Optical Discoloration 5 5
Electrical /Electronic Property Problem 4 4
Fluid/Blood Leak 3 3
Communication or Transmission Problem 3 3
Fracture 3 3
Intermittent Loss of Power 3 3
Unintended Power Up 3 3
Positioning Problem 3 3
Application Program Freezes, Becomes Nonfunctional 2 2
Power Problem 2 2
Device Damaged by Another Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Fogging 2 2
Connection Problem 2 2
Unintended Electrical Shock 2 2
Display Difficult to Read 2 2
Material Split, Cut or Torn 2 2
Unstable 2 2
Application Network Problem 1 1
Device Reprocessing Problem 1 1
Appropriate Term/Code Not Available 1 1
Self-Activation or Keying 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Excessive Heating 1 1
Device Displays Incorrect Message 1 1
Noise, Audible 1 1
Ambient Noise Problem 1 1
Device Emits Odor 1 1
Decreased Sensitivity 1 1
No Apparent Adverse Event 1 1
Activation Failure 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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