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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 57
Mechanical jam 53
Misfire 50
Failure to form staple 28
Difficult to open or close 27
No Known Device Problem 13
Device operates differently than expected 12
Difficult to remove 12
Break 10
Device Issue 9
Failure to cut 8
Failure to Adhere or Bond 7
Sticking 5
Unknown (for use when the device problem is not known) 4
Failure to separate 4
Failure to deploy 4
Entrapment of device or device component 4
Fluid leak 4
Leak 3
Air leak 3
Bent 2
Material disintegration 2
Replace 2
Malfunction 2
Difficult to deploy 2
Other (for use when an appropriate device code cannot be identified) 2
Failure to fire 2
Material deformation 2
No Information 2
Noise, Audible 2
Torn material 1
Device packaging compromised 1
Chemical issue 1
Detachment of device or device component 1
Defective item 1
Device displays error message 1
Device, removal of (non-implant) 1
Failure to align 1
Slippage of device or device component 1
Failure, intermittent 1
Mechanical issue 1
Unsealed device packaging 1
Product quality issue 1
Device, or device fragments remain in patient 1
Detachment of device component 1
Blockage within device or device component 1
Abnormal 1
Total Device Problems 354

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 2 1 0 0 0
Class III 0 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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