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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

Device Problems
Activation, Positioning or Separation Problem 66
Positioning Failure 44
Break 20
Sticking 15
Device-Device Incompatibility 15
Mechanical Jam 12
Firing Problem 8
Difficult to Open or Close 6
Mechanical Problem 6
Premature Activation 5
Separation Failure 5
Failure to Fire 5
Activation Problem 4
Unknown (for use when the device problem is not known) 4
Material Twisted / Bent 3
Detachment Of Device Component 3
Material Separation 2
Device Operates Differently Than Expected 2
Unintended Ejection 2
Difficult to Remove 2
Misfire 2
Detachment of Device or device Component 2
Difficult or Delayed Positioning 1
Physical Resistance / Sticking 1
Fracture 1
Connection Problem 1
Degraded 1
Needle 1
Melted 1
Delivered as Unsterile Product 1
Failure to Disconnect 1
Deformation Due to Compressive Stress 1
Loss of or Failure to Bond 1
Component Falling 1
Material Disintegration 1
Failure to Advance 1
Device Dislodged or Dislocated 1
Material Deformation 1
Material Integrity Problem 1
Migration or Expulsion of Device 1
Total Device Problems 251


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