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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Deployment issue 44
Difficult to open or close 21
Unknown (for use when the device problem is not known) 20
Sticking 15
Break 12
Degraded 11
Premature deployment 4
Failure to separate 4
Difficult to remove 3
Tip breakage 3
Detachment of device component 3
Failure to deploy 2
Unintended ejection 2
Mechanical issue 2
Migration of device or device component 1
Material disintegration 1
Entrapment of device or device component 1
Component falling 1
Difficult to deploy 1
Failure to fire 1
Failure to align 1
Misfire 1
Dislodged or dislocated 1
Mechanical jam 1
Total Device Problems 156

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