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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 28
Material Fragmentation 2
Material Separation 2
Detachment of Device or device Component 1
Dull, Blunt 1
Switch, Push Button 1
Cutter 1
Fracture 1
Device Operates Differently Than Expected 1
Adverse Event Without Identified Device or Use Problem 1
Use of Device Problem 1
Component Missing 1
Appropriate Term/Code Not Available 1
Material Split, Cut or Torn 1
Total Device Problems 43


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