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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 clip, hemostatic
Regulation Description Implantable clip.
Product CodeMCH
Regulation Number 878.4300
Device Class 2

Device Problems
Activation, Positioning or Separation Problem 120
Clip 57
Difficult to Open or Close 33
Migration or Expulsion of Device 14
Break 14
Device Slipped 5
Unintended Movement 4
Material Deformation 3
Premature Activation 3
Detachment of Device or device Component 3
Bushing 3
Device Dislodged or Dislocated 3
Human-Device Interface Problem 2
Unsealed Device Packaging 2
Material Fragmentation 1
Device Contamination with Chemical or Other Material 1
Flaked 1
Defective Device 1
Material Disintegration 1
Appropriate Term/Code Not Available 1
Total Device Problems 272

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Apr-05-2016

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