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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
2014 43 43
2015 26 26
2016 33 33
2017 40 40
2018 60 60
2019 28 28
2020 28 28
2021 32 32
2022 35 35
2023 18 18
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 81 81
Mechanical Jam 42 42
Suction Problem 20 20
Corroded 20 20
Mechanical Problem 20 20
Failure to Cut 18 18
Adverse Event Without Identified Device or Use Problem 16 16
Physical Resistance/Sticking 13 13
Detachment of Device or Device Component 13 13
Difficult to Open or Close 13 13
Misfire 12 12
Entrapment of Device 11 11
Difficult to Remove 9 9
Sticking 9 9
Insufficient Information 9 9
Device Operates Differently Than Expected 9 9
Material Separation 8 8
Fracture 7 7
Material Fragmentation 7 7
Delivered as Unsterile Product 6 6
Contamination /Decontamination Problem 6 6
Activation, Positioning or Separation Problem 5 5
Material Integrity Problem 5 5
Detachment Of Device Component 5 5
Component Missing 5 5
Stretched 4 4
Improper or Incorrect Procedure or Method 3 3
Packaging Problem 3 3
Mechanics Altered 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 2 2
Material Too Rigid or Stiff 2 2
Leak/Splash 2 2
Crack 2 2
Positioning Failure 1 1
Material Disintegration 1 1
Material Erosion 1 1
Device Reprocessing Problem 1 1
Loose or Intermittent Connection 1 1
Material Frayed 1 1
Unsealed Device Packaging 1 1
Pitted 1 1
Loss of Power 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Moisture Damage 1 1
Device Inoperable 1 1
Metal Shedding Debris 1 1
Shipping Damage or Problem 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Dent in Material 1 1
Device Fell 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Failure to Eject 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Scratched Material 1 1
Temperature Problem 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Material Perforation 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Device Displays Incorrect Message 1 1
Failure to Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 92 92
No Clinical Signs, Symptoms or Conditions 82 82
No Known Impact Or Consequence To Patient 62 62
No Patient Involvement 30 30
No Information 22 22
Hematoma 20 20
Tissue Damage 17 17
Insufficient Information 15 15
Foreign Body In Patient 10 10
Device Embedded In Tissue or Plaque 4 4
Not Applicable 4 4
Unspecified Tissue Injury 4 4
Hemorrhage/Bleeding 4 4
Laceration(s) 3 3
Perforation of Vessels 3 4
Death 3 3
Vascular Dissection 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Excessive Tear Production 2 2
Cardiac Perforation 2 2
Blood Loss 1 1
Complaint, Ill-Defined 1 1
Atrial Perforation 1 1
Great Vessel Perforation 1 1
Cardiac Tamponade 1 1
Neurological Deficit/Dysfunction 1 1
Occlusion 1 1
Perforation 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
No Code Available 1 1
Unspecified Vascular Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biorep Technologies II May-02-2014
2 Cincinnati Sub-Zero Products Inc II Nov-22-2016
3 Cook Vandergrift, Inc. II Sep-01-2023
4 Deroyal Industries, Inc. Lafollette II Feb-19-2020
5 Edwards Lifesciences, LLC II Jun-13-2013
6 Genesee BioMedical, Inc. II May-29-2018
7 International Biophysics Corp. II Aug-19-2015
8 Maquet Cardiovascular, LLC II Jul-31-2023
9 Maquet Cardiovascular, LLC II Apr-12-2022
10 Medtronic Perfusion Systems I Nov-01-2010
11 St. Jude Medical Cardiovascular Division II Feb-17-2011
12 Symmetry Medical/SSI II May-07-2013
13 TELEFLEX MEDICAL INC II Jan-27-2020
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