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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, automatic carbon-dioxide for endoscope
Regulation Description Endoscope and accessories.
Product CodeFCX
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
IDE VISION LTD
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALLIARE LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 12 12
2022 29 29
2023 54 54
2024 35 35
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 30 30
Pressure Problem 22 22
No Apparent Adverse Event 15 15
Pumping Stopped 14 14
Device Alarm System 11 11
Device Handling Problem 11 11
Intermittent Loss of Power 5 5
Output Problem 5 5
Electrical /Electronic Property Problem 5 5
Device Reprocessing Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Infusion or Flow Problem 4 4
Unexpected Shutdown 3 3
Gas Output Problem 3 3
Defective Component 3 3
Use of Device Problem 3 3
Improper Flow or Infusion 3 3
Noise, Audible 2 2
No Display/Image 2 2
Activation Problem 2 2
Complete Loss of Power 2 2
Incorrect Interpretation of Signal 2 2
Obstruction of Flow 2 2
Gas/Air Leak 2 2
Decrease in Pressure 2 2
Intermittent Communication Failure 1 1
No Flow 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Power Problem 1 1
Low Audible Alarm 1 1
Explosion 1 1
Environmental Particulates 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Use of Incorrect Control/Treatment Settings 1 1
Insufficient Flow or Under Infusion 1 1
Inaccurate Flow Rate 1 1
Failure to Power Up 1 1
Unintended Application Program Shut Down 1 1
Operating System Version or Upgrade Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Clean Adequately 1 1
Unintended Electrical Shock 1 1
Crack 1 1
Sensing Intermittently 1 1
Break 1 1
Chemical Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 102 102
Insufficient Information 28 28
Bradycardia 4 4
Perforation 2 2
Cardiac Arrest 2 2
No Consequences Or Impact To Patient 2 2
Abdominal Pain 1 1
Air Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1
Bowel Perforation 1 1
Inflammation 1 1
Bowel Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Northgate Technologies, Inc. II Feb-24-2021
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