Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device instruments, surgical, cardiovascular
Regulation Description Cardiovascular surgical instruments.
Product CodeDWS
Regulation Number 870.4500
Device Class 1

MDR Year MDR Reports MDR Events
2016 33 33
2017 40 40
2018 60 60
2019 28 28
2020 28 28
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
Mechanical Jam 25 25
Corroded 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Difficult to Open or Close 12 12
Failure to Cut 11 11
Misfire 9 9
Fracture 7 7
Mechanical Problem 7 7
Material Separation 6 6
Detachment of Device or Device Component 6 6
Device Operates Differently Than Expected 6 6
Contamination /Decontamination Problem 6 6
Delivered as Unsterile Product 6 6
Sticking 5 5
Detachment Of Device Component 5 5
Material Integrity Problem 4 4
Physical Resistance/Sticking 4 4
Difficult to Remove 4 4
Stretched 4 4
Component Missing 3 3
Material Fragmentation 3 3
Activation, Positioning or SeparationProblem 3 3
Packaging Problem 3 3
Tip 3 3
Entrapment of Device 3 3
Leak/Splash 2 2
Knife 2 2
No Apparent Adverse Event 2 2
Material Too Rigid or Stiff 2 2
Shipping Damage or Problem 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Material Perforation 1 1
Crack 1 1
Material Disintegration 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Off-Label Use 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Failure to Eject 1 1
Physical Property Issue 1 1
Catheter 1 1
Cable, Electrical 1 1
Device Or Device Fragments Location Unknown 1 1
Device Dislodged or Dislocated 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Material Erosion 1 1
Material Frayed 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Dent in Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Device Fell 1 1
Mechanics Altered 1 1
Positioning Problem 1 1
Scratched Material 1 1
Handpiece 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 70 70
No Known Impact Or Consequence To Patient 47 47
No Patient Involvement 29 29
No Information 17 17
Tissue Damage 14 14
Foreign Body In Patient 4 4
Device Embedded In Tissue or Plaque 4 4
Not Applicable 4 4
Hemorrhage/Bleeding 4 4
Laceration(s) 2 2
Death 2 2
Great Vessel Perforation 1 1
Complaint, Ill-Defined 1 1
Cardiac Perforation 1 1
Blood Loss 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Atrial Perforation 1 1
Failure of Implant 1 1
Perforation 1 1
Perforation of Vessels 1 2

Recalls
Manufacturer Recall Class Date Posted
1 Cincinnati Sub-Zero Products Inc II Nov-22-2016
2 Deroyal Industries, Inc. Lafollette II Feb-19-2020
3 Genesee BioMedical, Inc. II May-29-2018
4 TELEFLEX MEDICAL INC II Jan-27-2020
-
-