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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dislodger, stone, flexible
Regulation Description Ureteral stone dislodger.
Product CodeFGO
Regulation Number 876.4680
Device Class 2

Device Problems
Peeled / Delaminated 20
Detachment of Device or device Component 20
Coil 19
Break 10
Detachment Of Device Component 7
Material Frayed 5
Tip 3
Material Deformation 3
Material Separation 2
Entrapment of Device 2
Difficult to Open or Close 2
Wire 2
Adverse Event Without Identified Device or Use Problem 2
Difficult to Remove 2
Migration or Expulsion of Device 1
Tear, Rip or Hole in Device Packaging 1
Delivered as Unsterile Product 1
Deformation Due to Compressive Stress 1
Material Split, Cut or Torn 1
Torn Material 1
Total Device Problems 105


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