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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 9
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Deployment issue 56
Mechanical jam 52
Misfire 40
Difficult to open or close 25
Failure to form staple 14
Device operates differently than expected 11
Device Issue 9
Break 9
Difficult to remove 5
Sticking 5
Unknown (for use when the device problem is not known) 4
Failure to separate 4
No Known Device Problem 3
Material deformation 2
Malfunction 2
Other (for use when an appropriate device code cannot be identified) 2
Replace 2
Failure to Adhere or Bond 2
Difficult to deploy 2
Failure to deploy 2
Material disintegration 2
Entrapment of device or device component 2
Failure, intermittent 1
Leak 1
Product quality issue 1
Device, or device fragments remain in patient 1
Bent 1
Blockage within device or device component 1
Slippage of device or device component 1
Abnormal 1
Failure to cut 1
Defective item 1
Device displays error message 1
Device, removal of (non-implant) 1
Failure to fire 1
Chemical issue 1
Device packaging compromised 1
Torn material 1
Total Device Problems 271

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 0 1 0 0 2 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II May-19-2010
2 Ethicon Endo-Surgery Inc II Sep-08-2014
3 Ethicon Endo-Surgery Inc II Mar-07-2013
4 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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