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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spatial imaging for display of endoscope position
Definition To detect and display the shape of an inserted endoscope.
Product CodePGU
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Incorrect Control/Treatment Settings 1 1
Loose or Intermittent Connection 1 1
Defective Component 1 1
Defective Device 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Pain 1 1
Skin Tears 1 1

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