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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 47
Adverse Event Without Identified Device or Use Problem 8
Fracture 3
Difficult to Open or Close 2
Activation, Positioning or Separation Problem 2
Material Twisted / Bent 2
Device Operates Differently Than Expected 2
Insufficient Information 1
Mechanical Problem 1
Suture 1
Failure to Fire 1
Difficult to Remove 1
Separation Failure 1
Malposition of device 1
Material Frayed 1
Total Device Problems 74

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

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