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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device applier, surgical, clip
Regulation Description Manual surgical instrument for general use.
Product CodeGDO
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Failure to form staple 185
Replace 172
Failure to advance 55
Device operates differently than expected 51
Break 43
Malfunction 37
Sticking 32
Component falling 29
Clips, scissored 27
Failure to deploy 26
Loose 26
Difficult to open or close 26
Misfire 25
Failure to fire 25
Detachment of device component 22
Device maintenance issue 21
Mechanical jam 21
No Known Device Problem 21
Failure to separate 20
Device Issue 19
Deployment issue 18
Failure to align 14
Unintended ejection 14
Dislodged or dislocated 13
Slippage of device or device component 8
Premature deployment 8
Detachment of device or device component 8
Close, difficult to 8
Difficult to remove 8
Difficult to deploy 7
Mechanical issue 6
Unknown (for use when the device problem is not known) 6
Failure to disconnect 6
Cut in material 5
Device inoperable 5
Other (for use when an appropriate device code cannot be identified) 4
Defective item 4
Difficult to position 4
Bent 4
Dislodged 3
Device Difficult to Setup or Prepare 3
Product quality issue 3
Device, removal of (non-implant) 3
Component missing 3
Tip breakage 3
Twisting 3
Failure to deliver 2
Tear, rip or hole in device packaging 2
Tears, rips, holes in device, device material 2
Failure to cut 2
Difficult or delayed activation 2
Loose or intermittent connection 2
Misconnection 2
Entrapment of device or device component 2
Fracture 2
Failure to Adhere or Bond 2
Component(s), broken 2
Material twisted 2
No Information 2
Unintended movement 1
Foreign material present in device 1
Material deformation 1
Naturally worn 1
Device packaging compromised 1
Application interface becomes non-functional or program exits abnormally 1
Air leak 1
Blockage within device or device component 1
Difficult to insert 1
Kinked 1
Failure, intermittent 1
Unsealed device packaging 1
Device, or device fragments remain in patient 1
Material puncture 1
Source, detachment from 1
Sterility 1
Failure to reset 1
Material separation 1
Physical resistance 1
Delayed charge time 1
System fails to activate 1
Use of Device Issue 1
Noise 1
Fitting problem 1
Incomplete or missing packaging 1
Total Device Problems 1105

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

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon Endo-Surgery Inc II Jul-19-2013
2 The Anspach Effort, Inc. II Mar-24-2016

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