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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
Break 53
Device operates differently than expected 52
Difficult to open or close 40
Malfunction 37
Sticking 32
Component falling 29
Clips, scissored 27
Failure to deploy 26
Loose 26
Misfire 25
Failure to fire 25
Failure to separate 23
Deployment issue 22
Detachment of device component 22
Device maintenance issue 21
Mechanical jam 21
No Known Device Problem 21
Failure to align 20
Device Issue 19
Premature deployment 19
Unintended ejection 18
Dislodged or dislocated 13
Difficult to remove 12
Detachment of device or device component 8
Close, difficult to 8
Slippage of device or device component 8
Entrapment of device or device component 8
Difficult to deploy 7
Difficult to position 6
Mechanical issue 6
Failure to disconnect 6
Unknown (for use when the device problem is not known) 6
Device inoperable 5
Cut in material 5
Defective item 4
Other (for use when an appropriate device code cannot be identified) 4
Bent 4
No Information 4
Failure to Adhere or Bond 3
Dislodged 3
Device Difficult to Setup or Prepare 3
Product quality issue 3
Component missing 3
Tip breakage 3
Twisting 3
Device, removal of (non-implant) 3
Failure to cut 2
Difficult or delayed activation 2
Failure to deliver 2
Tear, rip or hole in device packaging 2
Tears, rips, holes in device, device material 2
Misconnection 2
Loose or intermittent connection 2
Fracture 2
Component(s), broken 2
Material twisted 2
Foreign material present in device 2
Material deformation 1
Naturally worn 1
Device packaging compromised 1
No code available 1
Unintended movement 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
System fails to activate 1
Use of Device Issue 1
Noise 1
Fitting problem 1
Incomplete or missing packaging 1
Physical resistance 1
Delayed charge time 1
Total Device Problems 1175

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 0 0 0 1 0 0 2 0
Class III 0 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 Teleflex Medical II Sep-08-2016
3 The Anspach Effort, Inc. II Mar-24-2016

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