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TPLC
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Show TPLC since
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Device
kit, surgical instrument, disposable
Regulation Description
Manual surgical instrument for general use.
Product Code
KDD
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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