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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
Misfire 53
Mechanical jam 51
Failure to form staple 27
Difficult to open or close 24
No Known Device Problem 13
Difficult to remove 13
Device operates differently than expected 12
Device Issue 9
Break 9
Failure to cut 8
Failure to Adhere or Bond 7
Sticking 5
Failure to separate 4
Air leak 4
Fluid leak 4
Unknown (for use when the device problem is not known) 4
Entrapment of device or device component 3
Failure to deploy 3
Other (for use when an appropriate device code cannot be identified) 3
Malfunction 2
Failure to fire 2
Material disintegration 2
Detachment of device component 2
Bent 2
Replace 2
Leak 2
Mechanical issue 2
Material deformation 2
No Information 2
Noise, Audible 2
Positioning Issue 1
Torn material 1
Unsealed device packaging 1
Product quality issue 1
Device, or device fragments remain in patient 1
Slippage of device or device component 1
Failure, intermittent 1
Blockage within device or device component 1
Abnormal 1
Difficult to deploy 1
Chemical issue 1
Device packaging compromised 1
Detachment of device or device component 1
Failure to align 1
Defective item 1
Device displays error message 1
Device, removal of (non-implant) 1
Total Device Problems 351

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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