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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, surgical instrument, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeKDD
Regulation Number 878.4800
Device Class 1

Device Problems
Delivered as Unsterile Product 27
Material Integrity Problem 8
Device Damaged by Another Device 7
Break 6
Appropriate Term/Code Not Available 6
Leak / Splash 5
Device Operates Differently Than Expected 5
Failure To Adhere Or Bond 5
Mechanical Problem 5
Device Contaminated during manufacture or shipping 4
Physical Property Issue 4
Fluid Leak 4
Electrical /Electronic Property Problem 4
Detachment of Device or device Component 4
Manufacturing, Packaging or Shipping Problem 3
Arcing 3
Material Fragmentation 3
Tear, Rip or Hole in Device Packaging 3
Product Quality Problem 3
Material Separation 2
Mechanical Jam 2
Device Contamination with Chemical or Other Material 2
Material Frayed 2
Adverse Event Without Identified Device or Use Problem 2
Air Leak 2
Fracture 2
Device Packaging Compromised 2
Degraded 2
Hole In Material 2
Material Perforation 2
Contamination / decontamination Problem 1
Activation, Positioning or Separation Problem 1
No Apparent Adverse Event 1
Device Difficult to Setup or Prepare 1
Improper or Incorrect Procedure or Method 1
Positioning Failure 1
Flaked 1
Material Distortion 1
Unsealed Device Packaging 1
Difficult To Position 1
Difficult to Insert 1
Defective Component 1
Strikethrough 1
Human Factors Issue 1
Power Problem 1
Unintended Ejection 1
Dull, Blunt 1
Defective Device 1
Material Deformation 1
Ejection Problem 1
Failure to Power Up 1
Tip 1
Device Issue 1
Total Device Problems 154

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-30-2018
2 Arrow International Inc II Apr-03-2018
3 Bioseal Corporation II Nov-09-2017
4 ROi Consolidated Service Center (CSC) II Aug-08-2019
5 Stryker Corporation II Mar-02-2018
6 Utah Medical Products, Inc II Nov-06-2015
7 Windstone Medical Packaging, Inc. II Dec-04-2015

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