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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device attachment, teaching, for endoscope
Product CodeFEA
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 3 3
2022 16 16
2023 21 21
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Erratic or Intermittent Display 9 9
No Display/Image 7 7
Unintended Movement 5 5
Optical Obstruction 3 3
Optical Distortion 2 2
Undercorrection 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 1 1

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