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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, removable (skin)
Regulation Description Removable skin staple.
Product CodeGDT
Regulation Number 878.4760
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical jam 164
Failure to form staple 111
Other (for use when an appropriate device code cannot be identified) 93
Misfire 46
Delivered as unsterile product 31
Loss of or failure to bond 29
Difficult to open or close 17
Deployment issue 16
Difficult to deploy 13
Mechanical issue 13
Replace 12
No Known Device Problem 11
Break 10
Unsealed device packaging 9
Dislodged or dislocated 7
Failure to fire 6
Failure to deploy 5
Premature deployment 4
Device operates differently than expected 4
Failure to deliver 4
Bent 3
No Information 3
Failure to align 2
Defective item 2
Entrapment of device or device component 2
Device Issue 2
Failure to separate 2
Loose 2
Detachment of device component 2
Sticking 2
Difficult to remove 2
Failure to cycle 2
No code available 2
Unintended ejection 2
Use of Device Issue 1
System fails to activate 1
Unknown (for use when the device problem is not known) 1
Invalid sensing 1
Twisting 1
Patient-device incompatibility 1
Noise 1
Failure to Adhere or Bond 1
Defective component 1
Clips, scissored 1
Environmental Particulates 1
Malfunction 1
Material erosion 1
Component(s), broken 1
Slippage of device or device component 1
Detachment of device or device component 1
Total Device Problems 651

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 0 0 0 0 0 0 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Sep-03-2015
2 Customed, Inc I Dec-16-2014
3 Teleflex Medical II Dec-14-2016

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