• 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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 54 54
Mechanical Jam 28 28
Corroded 17 17
Difficult to Open or Close 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Misfire 11 11
Failure to Cut 11 11
Mechanical Problem 8 8
Fracture 7 7
Delivered as Unsterile Product 6 6
Contamination /Decontamination Problem 6 6
Detachment of Device or Device Component 6 6
Device Operates Differently Than Expected 6 6
Material Separation 6 6
Sticking 5 5
Difficult to Remove 5 5
Detachment Of Device Component 5 5
Physical Resistance/Sticking 5 5
Material Integrity Problem 4 4
Stretched 4 4
Component Missing 3 3
Activation, Positioning or SeparationProblem 3 3
Material Fragmentation 3 3
Entrapment of Device 3 3
Packaging Problem 3 3
No Apparent Adverse Event 2 2
Material Too Rigid or Stiff 2 2
Leak/Splash 2 2
Improper or Incorrect Procedure or Method 2 2
Material Perforation 1 1
Device Or Device Fragments Location Unknown 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Dent in Material 1 1
Device Inoperable 1 1
Shipping Damage or Problem 1 1
Loose or Intermittent Connection 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
Material Erosion 1 1
Material Frayed 1 1
Crack 1 1
Material Disintegration 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Failure to Eject 1 1
Device Fell 1 1
Mechanics Altered 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Scratched Material 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 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 Clinical Signs, Symptoms or Conditions 22 22
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Perforation 1 1
Failure of Implant 1 1
Complaint, Ill-Defined 1 1
Atrial Perforation 1 1
Cardiac Perforation 1 1
Blood Loss 1 1
Vascular Dissection 1 1
Perforation of Vessels 1 2
Great Vessel Perforation 1 1

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
-
-