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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
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 22 22
2019 6 6
2020 5 5
2021 3 3
2022 19 19
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Reflux within Device 12 12
Pressure Problem 10 10
Appropriate Term/Code Not Available 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Energy Output Problem 4 4
Increase in Pressure 3 3
Calibration Problem 3 3
Use of Device Problem 2 2
Defective Device 2 2
Fluid/Blood Leak 2 2
Excess Flow or Over-Infusion 2 2
No Flow 2 2
Backflow 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Self-Activation or Keying 1 1
Device Displays Incorrect Message 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 11 11
Hemorrhage/Bleeding 10 10
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 2 2
Fall 2 2
Laceration(s) 2 2
Perforation 2 2
Swelling 2 2
Excessive Tear Production 1 1
Injury 1 1
Skin Tears 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Abdominal Pain 1 1

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