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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 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 66 66
Mechanical Jam 33 33
Corroded 20 20
Difficult to Open or Close 13 13
Mechanical Problem 12 12
Physical Resistance/Sticking 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 11 11
Misfire 11 11
Failure to Cut 11 11
Material Fragmentation 7 7
Entrapment of Device 6 6
Delivered as Unsterile Product 6 6
Contamination /Decontamination Problem 6 6
Fracture 6 6
Device Operates Differently Than Expected 5 5
Difficult to Remove 5 5
Material Separation 5 5
Detachment Of Device Component 4 4
Component Missing 4 4
Insufficient Information 4 4
Activation, Positioning or Separation Problem 3 3
Material Too Rigid or Stiff 2 2
Sticking 2 2
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 2 2
Material Integrity Problem 2 2
No Apparent Adverse Event 2 2
Packaging Problem 2 2
Physical Property Issue 1 1
Positioning Problem 1 1
Scratched Material 1 1
Noise, Audible 1 1
Failure to Eject 1 1
Device Fell 1 1
Loose or Intermittent Connection 1 1
Pitted 1 1
Material Perforation 1 1
Crack 1 1
Material Disintegration 1 1
Material Erosion 1 1
Material Frayed 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
No Consequences Or Impact To Patient 65 65
No Known Impact Or Consequence To Patient 31 31
No Patient Involvement 29 29
Tissue Damage 14 14
No Information 14 14
Foreign Body In Patient 10 10
Insufficient Information 9 9
Unspecified Tissue Injury 4 4
Device Embedded In Tissue or Plaque 4 4
Not Applicable 4 4
Vascular Dissection 3 3
Laceration(s) 3 3
Perforation of Vessels 2 3
Cardiac Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Blood Loss 1 1
Cardiac Tamponade 1 1
Perforation 1 1
Death 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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