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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device trocar
Regulation Description Trocar.
Product CodeDRC
Regulation Number 870.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2016 62 62
2017 70 70
2018 85 85
2019 95 95
2020 108 108
2021 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 336 336
Break 71 71
Activation, Positioning or SeparationProblem 29 29
Difficult to Insert 10 10
Detachment of Device or Device Component 7 7
Use of Device Problem 5 5
Bent 4 4
Material Separation 4 4
Appropriate Term/Code Not Available 4 4
Contamination /Decontamination Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Fracture 3 3
Material Fragmentation 3 3
Defective Device 2 2
Device Operates Differently Than Expected 2 2
Device Contaminated During Manufacture or Shipping 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Advance 2 2
Scratched Material 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Detachment Of Device Component 2 2
Entrapment of Device 1 1
Flaked 1 1
Failure To Adhere Or Bond 1 1
Partial Blockage 1 1
Delivered as Unsterile Product 1 1
Unintended Collision 1 1
Material Rupture 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Gas Leak 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Device Or Device Fragments Location Unknown 1 1
Inflation Problem 1 1
Mechanical Problem 1 1
Particulates 1 1
Difficult to Remove 1 1
Complete Blockage 1 1
Crack 1 1
Positioning Failure 1 1
Air Leak 1 1
Loss of or Failure to Bond 1 1
Component Missing 1 1
Expiration Date Error 1 1
Physical Resistance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 269 269
No Known Impact Or Consequence To Patient 69 69
No Consequences Or Impact To Patient 28 28
Death 20 20
No Clinical Signs, Symptoms or Conditions 19 19
Pericardial Effusion 18 18
Stroke/CVA 12 12
No Patient Involvement 11 11
Cardiac Tamponade 10 10
Perforation 7 7
Great Vessel Perforation 7 7
No Code Available 6 6
Cardiac Arrest 5 5
Low Blood Pressure/ Hypotension 5 5
Air Embolism 4 4
Device Embedded In Tissue or Plaque 4 4
No Information 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Transient Ischemic Attack 3 3
Vascular Dissection 3 3
Thrombus 2 2
Aortic Dissection 2 2
Needle Stick/Puncture 2 2
Pain 2 2
Arrhythmia 2 2
Embolus 2 2
Hemothorax 2 2
Myocardial Infarction 1 1
Hemorrhage/Bleeding 1 1
Edema 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Respiratory Failure 1 1
Perforation of Vessels 1 1
ST Segment Elevation 1 1
Extravasation 1 1
Occlusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. I Mar-13-2019
2 CooperSurgical, Inc. II May-01-2018
3 Merit Medical Systems, Inc. II Mar-16-2021
4 Merit Medical Systems, Inc. II Apr-12-2016
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