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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 474 474

Device Problems MDRs with this Device Problem Events in those MDRs
Break 78 78
Pumping Problem 76 76
Key or Button Unresponsive/not Working 72 72
Failure to Pump 50 50
Insufficient Flow or Under Infusion 26 26
Infusion or Flow Problem 20 20
Mechanical Problem 19 19
Free or Unrestricted Flow 14 14
Improper Flow or Infusion 13 13
Crack 13 13
Leak/Splash 11 11
Pressure Problem 10 10
No Device Output 8 8
Detachment of Device or Device Component 7 7
Loose or Intermittent Connection 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Decreased Pump Speed 6 6
Defective Device 6 6
Reflux within Device 5 5
Activation Problem 5 5
Output Problem 5 5
Defective Component 5 5
Fluid/Blood Leak 5 5
No Flow 4 4
Energy Output Problem 4 4
Intermittent Loss of Power 4 4
Flushing Problem 4 4
Gas/Air Leak 4 4
Electrical /Electronic Property Problem 4 4
Material Integrity Problem 3 3
Pumping Stopped 3 3
Power Problem 3 3
Connection Problem 3 3
Naturally Worn 3 3
Backflow 3 3
Restricted Flow rate 2 2
Degraded 2 2
Appropriate Term/Code Not Available 2 2
Increase in Pressure 2 2
Excess Flow or Over-Infusion 2 2
Inaccurate Flow Rate 2 2
Decrease in Pressure 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Prime 2 2
Intermittent Infusion 2 2
No Display/Image 2 2
Use of Device Problem 2 2
Circuit Failure 2 2
Failure to Power Up 2 2
Communication or Transmission Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 484 484
Hemorrhage/Bleeding 10 10
Insufficient Information 7 7
No Consequences Or Impact To Patient 5 5
Bowel Perforation 2 2
Perforation 2 2
Laceration(s) 2 2
Fall 2 2
Abdominal Pain 1 1
Patient Problem/Medical Problem 1 1
Blood Loss 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Excessive Tear Production 1 1

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