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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bulb, inflation, for endoscope
Definition An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.
Product CodeFCY
Regulation Number 876.1500
Device Class 1


Premarket Reviews
ManufacturerDecision
ZUTRON MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2020 1 1
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5 5
Fluid/Blood Leak 2 2
No Pressure 2 2
Material Split, Cut or Torn 2 2
Unintended Electrical Shock 1 1
Crack 1 1
Mechanical Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Electric Shock 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

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