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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 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Corroded 23 23
Mechanical Jam 14 14
Physical Resistance/Sticking 13 13
Adverse Event Without Identified Device or Use Problem 10 10
Mechanical Problem 9 9
Failure to Cut 8 8
Detachment of Device or Device Component 8 8
Insufficient Information 7 7
Material Fragmentation 6 6
Material Separation 5 5
Entrapment of Device 4 4
Improper or Incorrect Procedure or Method 4 4
Material Integrity Problem 3 3
Component Missing 3 3
Packaging Problem 3 3
Fracture 3 3
Difficult to Open or Close 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
No Pressure 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Difficult or Delayed Activation 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 93 93
Insufficient Information 21 21
No Patient Involvement 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
Vascular Dissection 4 4
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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