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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cutter, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeFZT
Regulation Number 878.4800
Device Class 1

Device Problems
Break 35
Material Fragmentation 2
Material Separation 2
Use of Device Problem 1
Component Missing 1
Dull, Blunt 1
Detachment of Device or device Component 1
Device Operates Differently Than Expected 1
Material Twisted / Bent 1
Adverse Event Without Identified Device or Use Problem 1
Positioning Problem 1
Switch, Push Button 1
Appropriate Term/Code Not Available 1
Material Split, Cut or Torn 1
Activation Problem 1
Inaccurate Information 1
Fracture 1
Cutter 1
Total Device Problems 54


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