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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blade, scalpel
Regulation Description Manual surgical instrument for general use.
Product CodeGES
Regulation Number 878.4800
Device Class 1

Device Problems
Break 25
Mechanical Problem 13
Dull, Blunt 10
Tear, Rip or Hole in Device Packaging 9
Material Integrity Problem 9
Failure to Cut 7
Device Operates Differently Than Expected 5
Manufacturing, Packaging or Shipping Problem 5
Fracture 4
Corroded 3
Adverse Event Without Identified Device or Use Problem 3
Delivered as Unsterile Product 2
Defective Device 2
Packaging Problem 2
Use of Device Problem 2
Product Quality Problem 2
Material Deformation 1
Device Handling Problem 1
Tip 1
Detachment Of Device Component 1
Device Disinfection Or Sterilization Issue 1
Device Contamination with Chemical or Other Material 1
Insufficient Information 1
Material Fragmentation 1
Incomplete or Missing Packaging 1
Contamination / decontamination Problem 1
Connection Problem 1
Unsealed Device Packaging 1
Total Device Problems 115

Recalls
Manufacturer Recall Class Date Posted
1 Aspen Surgical Puerto Rico Corp. II Sep-08-2016

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