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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 instrument, ligature passing and knot tying
Regulation Description Manual surgical instrument for general use.
Product CodeHCF
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 54
Adverse Event Without Identified Device or Use Problem 9
Material Twisted/Bent 5
Fracture 3
Insufficient Information 2
Activation, Positioning or SeparationProblem 2
Fastener 2
Difficult to Open or Close 1
Positioning Failure 1
Mechanical Jam 1
Material Frayed 1
Loose or Intermittent Connection 1
Mechanical Problem 1
Difficult to Remove 1
Improper or Incorrect Procedure or Method 1
Component Missing 1
Failure to Advance 1
Separation Failure 1
Failure to Fire 1
Malposition of Device 1
Total Device Problems 90

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Dec-14-2016
2 Teleflex Medical II Aug-15-2016

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