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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device trocar
Product CodeDRC
Regulation Number 870.1390
Device Class 2


Premarket Reviews
ManufacturerDecision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 5
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 62 62
2017 70 70
2018 85 85
2019 95 95
2020 108 108
2021 78 78
2022 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 372 372
Break 73 73
Activation, Positioning or SeparationProblem 29 29
Difficult to Insert 12 12
Detachment of Device or Device Component 9 9
Material Separation 8 8
Fracture 7 7
Device Contamination with Chemical or Other Material 5 5
Use of Device Problem 5 5
Appropriate Term/Code Not Available 4 4
Contamination /Decontamination Problem 4 4
Material Fragmentation 4 4
Bent 4 4
Gas Leak 4 4
Corroded 3 3
Leak/Splash 2 2
Device Contaminated During Manufacture or Shipping 2 2
Physical Resistance/Sticking 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Advance 2 2
Detachment Of Device Component 2 2
Device Operates Differently Than Expected 2 2
Difficult to Remove 2 2
Difficult to Advance 2 2
Loose or Intermittent Connection 2 2
Scratched Material 2 2
Component Missing 2 2
Defective Device 2 2
Device Or Device Fragments Location Unknown 1 1
Crack 1 1
Mechanical Problem 1 1
Particulates 1 1
Loss of or Failure to Bond 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Component Misassembled 1 1
Positioning Problem 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Entrapment of Device 1 1
Flaked 1 1
Air Leak 1 1
Expiration Date Error 1 1
Physical Resistance 1 1
Complete Blockage 1 1
Positioning Failure 1 1
Inflation Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Device-Device Incompatibility 1 1
Unintended Collision 1 1
Failure To Adhere Or Bond 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 296 296
No Known Impact Or Consequence To Patient 69 69
No Clinical Signs, Symptoms or Conditions 35 35
No Consequences Or Impact To Patient 28 28
Pericardial Effusion 24 24
Death 20 20
Cardiac Tamponade 13 13
Stroke/CVA 12 12
No Patient Involvement 11 11
Low Blood Pressure/ Hypotension 8 8
Perforation 8 8
Great Vessel Perforation 8 8
Foreign Body In Patient 7 7
Cardiac Arrest 6 6
No Code Available 6 6
Air Embolism 5 5
Device Embedded In Tissue or Plaque 4 4
No Information 3 3
Patient Problem/Medical Problem 3 3
Vascular Dissection 3 3
Transient Ischemic Attack 3 3
Pain 2 2
Thrombus 2 2
Needle Stick/Puncture 2 2
Aortic Dissection 2 2
Arrhythmia 2 2
Embolus 2 2
Hemorrhage/Bleeding 2 2
Hemothorax 2 2
Myocardial Infarction 1 1
Occlusion 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
ST Segment Elevation 1 1
Extravasation 1 1
Hematoma 1 1
Edema 1 1
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Respiratory Failure 1 1
Perforation of Vessels 1 1
Foreign Body Embolism 1 1

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