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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 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 36 36
Pressure Problem 25 25
No Apparent Adverse Event 16 16
Pumping Stopped 14 14
Electrical /Electronic Property Problem 13 13
Device Alarm System 12 12
Device Handling Problem 11 11
Output Problem 11 11
Unexpected Shutdown 7 7
Gas Output Problem 6 6
Device Reprocessing Problem 5 5
Intermittent Loss of Power 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Infusion or Flow Problem 4 4
Use of Device Problem 3 3
Defective Component 3 3
Improper Flow or Infusion 3 3
Incorrect Interpretation of Signal 2 2
Activation Problem 2 2
Obstruction of Flow 2 2
Complete Loss of Power 2 2
No Display/Image 2 2
Noise, Audible 2 2
Gas/Air Leak 2 2
Mechanical Problem 2 2
Decrease in Pressure 2 2
Failure to Clean Adequately 1 1
Intermittent Communication Failure 1 1
Unintended Application Program Shut Down 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unintended Electrical Shock 1 1
Explosion 1 1
Power Problem 1 1
Operating System Version or Upgrade Problem 1 1
No Flow 1 1
Medical Gas Supply Problem 1 1
Product Quality Problem 1 1
Failure to Power Up 1 1
Leak/Splash 1 1
Environmental Particulates 1 1
Contamination /Decontamination Problem 1 1
Chemical Problem 1 1
Inaccurate Flow Rate 1 1
Crack 1 1
Use of Incorrect Control/Treatment Settings 1 1
Circuit Failure 1 1
Break 1 1
Low Audible Alarm 1 1
Insufficient Flow or Under Infusion 1 1
Sensing Intermittently 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 126 126
Insufficient Information 35 35
Bradycardia 4 4
Perforation 2 2
No Consequences Or Impact To Patient 2 2
Cardiac Arrest 2 2
Bowel Perforation 1 1
Abdominal Pain 1 1
Air Embolism 1 1
Bowel Burn 1 1
Inflammation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1

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