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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
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 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 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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