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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
Use of Device Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Gas Leak 4 4
Material Fragmentation 4 4
Bent 4 4
Contamination /Decontamination Problem 4 4
Appropriate Term/Code Not Available 4 4
Corroded 3 3
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Operates Differently Than Expected 2 2
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Advance 2 2
Difficult to Remove 2 2
Defective Device 2 2
Scratched Material 2 2
Detachment Of Device Component 2 2
Difficult to Advance 2 2
Physical Resistance/Sticking 2 2
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Component Misassembled 1 1
Device Or Device Fragments Location Unknown 1 1
Material Rupture 1 1
Expiration Date Error 1 1
Physical Resistance 1 1
Device-Device Incompatibility 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Unintended Collision 1 1
Particulates 1 1
Inflation Problem 1 1
Complete Blockage 1 1
Crack 1 1
Positioning Failure 1 1
Entrapment of Device 1 1
Flaked 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Air Leak 1 1
Failure To Adhere Or Bond 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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