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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 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Break 44 44
Corroded 22 22
Physical Resistance/Sticking 13 13
Mechanical Jam 13 13
Adverse Event Without Identified Device or Use Problem 10 10
Mechanical Problem 8 8
Failure to Cut 8 8
Detachment of Device or Device Component 8 8
Insufficient Information 6 6
Material Fragmentation 6 6
Material Separation 4 4
Entrapment of Device 3 3
Component Missing 3 3
Packaging Problem 3 3
Fracture 3 3
Difficult to Open or Close 3 3
Improper or Incorrect Procedure or Method 3 3
Leak/Splash 2 2
Difficult to Remove 2 2
Misfire 2 2
Crack 1 1
Device Markings/Labelling Problem 1 1
Material Erosion 1 1
Separation Failure 1 1
Device Fell 1 1
Material Integrity Problem 1 1
No Pressure 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Material Perforation 1 1
Mechanics Altered 1 1
Pitted 1 1
Loose or Intermittent Connection 1 1
Failure to Disconnect 1 1
Dull, Blunt 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
No Patient Involvement 18 18
Insufficient Information 18 18
No Consequences Or Impact To Patient 18 18
No Information 10 10
No Known Impact Or Consequence To Patient 8 8
Foreign Body In Patient 8 8
Tissue Damage 8 8
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Vascular Dissection 3 3
Laceration(s) 3 3
Perforation of Vessels 3 4
Cardiac Perforation 2 2
Death 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 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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