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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device pump, air, non-manual, for endoscope
Regulation Description Endoscope and accessories.
Product CodeFEQ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ERBE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATE ENDOSCOPY GROUP, INC.
  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
2016 1 1
2017 4 4
2018 22 22
2019 6 6
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Reflux within Device 12 12
Pressure Problem 6 6
Fluid Leak 3 3
Calibration Problem 3 3
Excess Flow or Over-Infusion 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Increase in Pressure 2 2
Self-Activation or Keying 1 1
Device Inoperable 1 1
Device Contamination with Body Fluid 1 1
Device Displays Incorrect Message 1 1
Device Contamination with Chemical or Other Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Calibrate 1 1
Device Operates Differently Than Expected 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 11 11
Swelling 2 2
Perforation 1 1
Excessive Tear Production 1 1
Skin Tears 1 1
Abdominal Pain 1 1
Exposure to Body Fluids 1 1
Injury 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1

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