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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
Break 75
Difficult to open or close 57
Failure to advance 55
Device operates differently than expected 52
Malfunction 37
Sticking 32
Deployment issue 32
Failure to align 29
Component falling 29
Failure to deploy 28
Clips, scissored 27
Failure to separate 26
Loose 26
Premature deployment 25
Misfire 25
Failure to fire 25
Detachment of device component 24
Unintended ejection 24
Device maintenance issue 21
Mechanical jam 21
No Known Device Problem 21
Detachment of device or device component 20
Device Issue 19
Dislodged or dislocated 14
Difficult to remove 12
Entrapment of device or device component 9
Difficult to position 9
Slippage of device or device component 8
Close, difficult to 8
Difficult to deploy 7
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
Bent 5
Defective item 4
Other (for use when an appropriate device code cannot be identified) 4
No Information 4
Tip breakage 3
Twisting 3
Component missing 3
Device, removal of (non-implant) 3
Failure to Adhere or Bond 3
Dislodged 3
Loose or intermittent connection 3
Device Difficult to Setup or Prepare 3
Product quality issue 3
Material separation 2
Misconnection 2
Fracture 2
Component(s), broken 2
Failure to cut 2
Failure to deliver 2
Difficult or delayed activation 2
Tear, rip or hole in device packaging 2
Tears, rips, holes in device, device material 2
Material twisted 2
Foreign material present in device 2
Material deformation 1
Device packaging compromised 1
Naturally worn 1
No code available 1
Unintended movement 1
Incomplete or missing packaging 1
Use of Device Issue 1
Noise 1
Fitting problem 1
Source, detachment from 1
Sterility 1
System fails to activate 1
Physical resistance 1
Delayed charge time 1
Device or device fragments location unknown 1
Crack 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
Unsealed device packaging 1
Failure, intermittent 1
Failure to reset 1
Device, or device fragments remain in patient 1
Material puncture 1
Total Device Problems 1274

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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