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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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 82 82
Optical Problem 47 47
Unintended Movement 38 38
Break 35 35
Product Quality Problem 33 33
Erratic or Intermittent Display 32 32
Image Display Error/Artifact 29 29
Poor Quality Image 22 22
Circuit Failure 18 18
Display or Visual Feedback Problem 13 13
Unintended System Motion 8 8
Data Problem 8 8
Device Markings/Labelling Problem 6 6
Failure to Power Up 6 6
Optical Distortion 6 6
Optical Discoloration 5 5
Patient Data Problem 5 5
Loose or Intermittent Connection 5 5
Computer Software Problem 5 5
Electrical /Electronic Property Problem 4 4
Fracture 3 3
Unintended Power Up 3 3
Optical Obstruction 3 3
Positioning Problem 3 3
Communication or Transmission Problem 3 3
Intermittent Loss of Power 3 3
Unintended Electrical Shock 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Material Split, Cut or Torn 2 2
Connection Problem 2 2
Device Damaged by Another Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Power Problem 2 2
Display Difficult to Read 2 2
Fluid/Blood Leak 2 2
Fogging 2 2
Unstable 2 2
Obstruction of Flow 1 1
Decreased Sensitivity 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Ambient Noise Problem 1 1
Application Network Problem 1 1
Blocked Connection 1 1
Mechanical Problem 1 1
Misconnection 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Failure to Transmit Record 1 1
Self-Activation or Keying 1 1
Leak/Splash 1 1
Degraded 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Unauthorized Access to Computer System 1 1
Output Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Lack of Maintenance Documentation or Guidelines 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 351 351
No Consequences Or Impact To Patient 24 24
Insufficient Information 16 16
No Known Impact Or Consequence To Patient 7 7
Electric Shock 2 2
Burn(s) 2 2
Undesired Nerve Stimulation 2 2
Pain 2 2
Vomiting 2 2
Melena 2 2
No Patient Involvement 1 1
No Information 1 1

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