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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 136
Failure to form staple 106
Other (for use when an appropriate device code cannot be identified) 93
Misfire 45
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 12
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
Failure to deliver 4
Device operates differently than expected 4
No Information 3
Bent 3
Entrapment of device or device component 2
Difficult to remove 2
Detachment of device component 2
Failure to cycle 2
Unintended ejection 2
Loose 2
Device Issue 2
Failure to align 2
Failure to separate 2
Sticking 2
No code available 2
Defective item 2
Patient-device incompatibility 1
Environmental Particulates 1
Detachment of device or device component 1
System fails to activate 1
Twisting 1
Use of Device Issue 1
Noise 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Invalid sensing 1
Clips, scissored 1
Malfunction 1
Slippage of device or device component 1
Material erosion 1
Failure to Adhere or Bond 1
Component(s), broken 1
Total Device Problems 616

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

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