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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scissors, general, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRW
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 28
Insulation, detached 5
Material integrity issue 4
Material fragmentation 3
Smoking 2
Device maintenance issue 2
Device, or device fragments remain in patient 2
Material separation 2
Inadequate service 1
Replace 1
Material puncture 1
Detachment of device component 1
Tip breakage 1
Use of Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Device Issue 1
Detachment of device or device component 1
Device operates differently than expected 1
No Information 1
No code available 1
Total Device Problems 60

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 1 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Jun-11-2008
2 Teleflex Medical II Apr-09-2009

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