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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, air, non-manual, for endoscope
Product CodeFEQ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 5 5
2021 3 3
2022 19 19
2023 12 12
2024 88 88

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Pumping Problem 11 11
Pressure Problem 7 7
Insufficient Flow or Under Infusion 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Key or Button Unresponsive/not Working 6 6
Detachment of Device or Device Component 5 5
Free or Unrestricted Flow 4 4
Crack 4 4
Energy Output Problem 4 4
Failure to Pump 4 4
Reflux within Device 4 4
Backflow 3 3
Decreased Pump Speed 3 3
Improper Flow or Infusion 3 3
No Flow 3 3
Appropriate Term/Code Not Available 2 2
Activation Problem 2 2
Infusion or Flow Problem 2 2
Gas/Air Leak 2 2
Defective Device 2 2
Use of Device Problem 2 2
Increase in Pressure 2 2
Failure to Prime 2 2
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 1 1
Flushing Problem 1 1
Degraded 1 1
No Display/Image 1 1
Contamination 1 1
No Device Output 1 1
Decrease in Pressure 1 1
Communication or Transmission Problem 1 1
Intermittent Infusion 1 1
Structural Problem 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Optical Obstruction 1 1
Output Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 101
Hemorrhage/Bleeding 10 10
No Consequences Or Impact To Patient 5 5
Insufficient Information 3 3
Bowel Perforation 2 2
Laceration(s) 2 2
Perforation 2 2
Fall 2 2
Abdominal Pain 1 1
Excessive Tear Production 1 1
Injury 1 1
Skin Tears 1 1
Blood Loss 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Swelling/ Edema 1 1

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