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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 282 282

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Problem 55 55
Break 47 47
Key or Button Unresponsive/not Working 29 29
Failure to Pump 23 23
Insufficient Flow or Under Infusion 12 12
Mechanical Problem 11 11
Infusion or Flow Problem 11 11
Free or Unrestricted Flow 10 10
Crack 10 10
Pressure Problem 9 9
Leak/Splash 8 8
Improper Flow or Infusion 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Detachment of Device or Device Component 5 5
Activation Problem 5 5
No Device Output 5 5
Decreased Pump Speed 5 5
Energy Output Problem 4 4
Reflux within Device 4 4
Loose or Intermittent Connection 4 4
Fluid/Blood Leak 4 4
Output Problem 4 4
Defective Device 4 4
No Flow 4 4
Connection Problem 3 3
Gas/Air Leak 3 3
Power Problem 3 3
Backflow 3 3
Pumping Stopped 3 3
Use of Device Problem 2 2
Intermittent Infusion 2 2
Decrease in Pressure 2 2
Increase in Pressure 2 2
Failure to Prime 2 2
Degraded 2 2
No Display/Image 2 2
Appropriate Term/Code Not Available 2 2
Intermittent Loss of Power 2 2
Communication or Transmission Problem 2 2
Naturally Worn 2 2
Optical Obstruction 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Activation Failure 1 1
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Positioning Problem 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Restricted Flow rate 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Fracture 1 1
Inflation Problem 1 1
Inability to Irrigate 1 1
Positioning Failure 1 1
Defective Alarm 1 1
Circuit Failure 1 1
Contamination 1 1
Corroded 1 1
Premature Activation 1 1
Moisture Damage 1 1
Structural Problem 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 292
Hemorrhage/Bleeding 10 10
Insufficient Information 6 6
No Consequences Or Impact To Patient 5 5
Laceration(s) 2 2
Perforation 2 2
Fall 2 2
Bowel Perforation 2 2
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Swelling/ Edema 1 1
Abdominal Pain 1 1
Excessive Tear Production 1 1
Injury 1 1
Skin Tears 1 1
Blood Loss 1 1

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