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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 22
Mechanical Problem 12
Material Integrity Problem 9
Tear, Rip or Hole in Device Packaging 8
Dull, Blunt 8
Failure to Cut 7
Device Operates Differently Than Expected 6
Manufacturing, Packaging or Shipping Problem 5
Fracture 4
Microscope 3
Corroded 3
Adverse Event Without Identified Device or Use Problem 3
Product Quality Problem 3
Out-Of-Box Failure 2
System 2
Delivered as Unsterile Product 2
Defective Device 2
Device Handling Problem 2
Contamination / decontamination Problem 1
Connection Problem 1
Detachment of Device or device Component 1
Device Disinfection Or Sterilization Issue 1
Unsealed Device Packaging 1
Material Fragmentation 1
Loose or Intermittent Connection 1
Detachment Of Device Component 1
Tip 1
Insufficient Information 1
Appropriate Term/Code Not Available 1
Packaging Problem 1
Material Deformation 1
Incomplete or Missing Packaging 1
Use of Device Problem 1
Component Missing 1
Device Contamination with Chemical or Other Material 1
Human-Device Interface Problem 1
Inadequate User Interface 1
Total Device Problems 122

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

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