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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 48
Difficult to open or close 27
Failure to form staple 26
Device operates differently than expected 12
Difficult to remove 11
No Known Device Problem 11
Break 10
Device Issue 9
Failure to cut 8
Failure to Adhere or Bond 5
Sticking 5
Failure to separate 4
Entrapment of device or device component 4
Unknown (for use when the device problem is not known) 4
Failure to deploy 3
Air leak 3
Leak 3
Material deformation 2
Malfunction 2
No Information 2
Noise, Audible 2
Other (for use when an appropriate device code cannot be identified) 2
Fluid leak 2
Difficult to deploy 2
Replace 2
Failure to fire 2
Material disintegration 2
Device, or device fragments remain in patient 1
Bent 1
Product quality issue 1
Chemical issue 1
Failure, intermittent 1
Device displays error message 1
Abnormal 1
Mechanical issue 1
Slippage of device or device component 1
Torn material 1
Failure to align 1
Defective item 1
Detachment of device component 1
Blockage within device or device component 1
Device, removal of (non-implant) 1
Device packaging compromised 1
Total Device Problems 339

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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