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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
2019 28 28
2020 28 28
2021 32 32
2022 35 35
2023 18 18
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
Corroded 19 19
Mechanical Jam 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Material Fragmentation 6 6
Detachment of Device or Device Component 6 6
Mechanical Problem 6 6
Insufficient Information 4 4
Physical Resistance/Sticking 4 4
Material Separation 3 3
Entrapment of Device 3 3
Difficult to Open or Close 3 3
Component Missing 3 3
Failure to Cut 3 3
Fracture 3 3
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Misfire 2 2
Packaging Problem 2 2
Leak/Splash 2 2
Separation Failure 1 1
Material Too Rigid or Stiff 1 1
Material Perforation 1 1
Noise, Audible 1 1
Crack 1 1
Failure to Disconnect 1 1
Loose or Intermittent Connection 1 1
Device Markings/Labelling Problem 1 1
Material Erosion 1 1
Mechanics Altered 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Pitted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
No Consequences Or Impact To Patient 18 18
No Patient Involvement 18 18
No Information 10 10
Insufficient Information 8 8
No Known Impact Or Consequence To Patient 8 8
Tissue Damage 8 8
Foreign Body In Patient 5 5
Unspecified Tissue Injury 4 4
Vascular Dissection 3 3
Perforation of Vessels 2 3
Laceration(s) 2 2
Cardiac Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Low Blood Pressure/ Hypotension 1 1
Cardiac Tamponade 1 1
Blood Loss 1 1
Death 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 Maquet Cardiovascular, LLC II Jul-31-2023
4 Maquet Cardiovascular, LLC II Apr-12-2022
5 TELEFLEX MEDICAL INC II Jan-27-2020
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