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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device applier, hemostatic clip
Regulation Description Manual surgical instrument for general use.
Product CodeHBT
Regulation Number 878.4800
Device Class 1

Device Problems
Mechanical issue 94
Deployment issue 27
Difficult to open or close 11
Mechanical jam 4
Misfire 3
Failure to separate 3
Difficult to remove 2
Break 2
Difficult to deploy 1
Failure to deploy 1
Unintended ejection 1
Sticking 1
Failure to align 1
Delivery system failure 1
Device operates differently than expected 1
Dislodged or dislocated 1
Total Device Problems 154

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 1 0 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atricure Inc II Mar-14-2014
2 Lemaitre Vascular, Inc. III Oct-28-2010
3 Sterilmed Inc II Jan-13-2009

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