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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instruments, surgical, cardiovascular
Product CodeDWS
Regulation Number 870.4500
Device Class 1

MDR Year MDR Reports MDR Events
2017 40 40
2018 60 60
2019 28 28
2020 28 28
2021 32 32
2022 35 35
2023 18 18
2024 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Break 67 67
Mechanical Jam 34 34
Corroded 22 22
Failure to Cut 16 16
Physical Resistance/Sticking 15 15
Difficult to Open or Close 13 13
Mechanical Problem 13 13
Detachment of Device or Device Component 11 11
Misfire 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Material Fragmentation 7 7
Fracture 6 6
Material Separation 6 6
Delivered as Unsterile Product 6 6
Entrapment of Device 6 6
Contamination /Decontamination Problem 6 6
Insufficient Information 6 6
Difficult to Remove 5 5
Device Operates Differently Than Expected 5 5
Component Missing 4 4
Detachment Of Device Component 4 4
Improper or Incorrect Procedure or Method 3 3
Activation, Positioning or Separation Problem 3 3
Packaging Problem 3 3
Material Too Rigid or Stiff 2 2
Leak/Splash 2 2
Material Integrity Problem 2 2
Sticking 2 2
No Apparent Adverse Event 2 2
Out-Of-Box Failure 1 1
Material Perforation 1 1
Mechanics Altered 1 1
Structural Problem 1 1
Use of Device Problem 1 1
Failure to Disconnect 1 1
Loose or Intermittent Connection 1 1
Scratched Material 1 1
Failure to Eject 1 1
Device Fell 1 1
Material Erosion 1 1
No Pressure 1 1
Dull, Blunt 1 1
Noise, Audible 1 1
Material Frayed 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Separation Failure 1 1
Pitted 1 1
Material Deformation 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
No Consequences Or Impact To Patient 65 65
No Known Impact Or Consequence To Patient 31 31
No Patient Involvement 29 29
Insufficient Information 18 18
No Information 14 14
Tissue Damage 14 14
Foreign Body In Patient 11 11
Not Applicable 4 4
Laceration(s) 4 4
Unspecified Tissue Injury 4 4
Device Embedded In Tissue or Plaque 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Vascular Dissection 3 3
Perforation of Vessels 3 4
Cardiac Perforation 2 2
Death 1 1
Perforation 1 1
Blood Loss 1 1
Cardiac Tamponade 1 1
Unspecified Vascular Problem 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Vandergrift, Inc. II Sep-01-2023
2 Deroyal Industries, Inc. Lafollette II Feb-19-2020
3 Genesee BioMedical, Inc. II May-29-2018
4 Maquet Cardiovascular, LLC II Jul-31-2023
5 Maquet Cardiovascular, LLC II Apr-12-2022
6 TELEFLEX MEDICAL INC II Jan-27-2020
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