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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
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 5
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 63 63
2015 51 51
2016 62 62
2017 70 70
2018 85 85
2019 95 95
2020 108 108
2021 78 78
2022 61 61
2023 109 109
2024 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 529 529
Break 95 95
Insufficient Information 33 33
Activation, Positioning or Separation Problem 32 32
Difficult to Insert 28 28
Fracture 23 23
Material Separation 10 10
Detachment of Device or Device Component 10 10
Gas/Air Leak 10 10
Unintended Movement 9 9
Material Twisted/Bent 8 8
Detachment Of Device Component 7 7
Appropriate Term/Code Not Available 7 7
Device Contamination with Chemical or Other Material 6 6
Device Contamination with Body Fluid 5 5
Bent 5 5
Inflation Problem 5 5
Positioning Problem 5 5
Contamination /Decontamination Problem 5 5
Device Operates Differently Than Expected 5 5
Use of Device Problem 5 5
Physical Resistance/Sticking 4 4
Difficult to Advance 4 4
Material Fragmentation 4 4
No Apparent Adverse Event 3 3
Mechanical Problem 3 3
Physical Resistance 3 3
Component Missing 3 3
Patient Device Interaction Problem 3 3
Difficult to Remove 3 3
Improper or Incorrect Procedure or Method 3 3
Corroded 3 3
Leak/Splash 3 3
Unexpected Therapeutic Results 2 2
Scratched Material 2 2
Failure to Advance 2 2
Defective Device 2 2
Material Protrusion/Extrusion 2 2
Loose or Intermittent Connection 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Puncture/Hole 2 2
Entrapment of Device 2 2
Malposition of Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Or Device Fragments Location Unknown 1 1
Device Inoperable 1 1
Failure to Disconnect 1 1
Partial Blockage 1 1
Inadequacy of Device Shape and/or Size 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 425 425
No Clinical Signs, Symptoms or Conditions 100 100
No Known Impact Or Consequence To Patient 86 86
Pericardial Effusion 84 84
Low Blood Pressure/ Hypotension 43 43
Cardiac Tamponade 40 40
No Consequences Or Impact To Patient 32 32
Death 24 24
Perforation 16 16
Stroke/CVA 15 15
No Patient Involvement 14 14
Great Vessel Perforation 11 11
Hemorrhage/Bleeding 9 9
Thrombosis/Thrombus 8 8
Foreign Body In Patient 7 7
Air Embolism 6 6
Device Embedded In Tissue or Plaque 6 6
Arrhythmia 6 6
No Code Available 6 6
Vascular Dissection 6 6
Cardiac Arrest 6 6
Insufficient Information 5 5
No Information 5 5
Hematoma 4 4
Transient Ischemic Attack 4 4
Perforation of Vessels 3 3
Pseudoaneurysm 3 3
Chest Pain 3 3
Needle Stick/Puncture 3 3
Hemothorax 3 3
Thrombus 3 3
Patient Problem/Medical Problem 3 3
Aortic Dissection 2 2
Discomfort 2 2
Embolus 2 2
Pain 2 2
Non specific EKG/ECG Changes 2 2
Tachycardia 2 2
Extubate 1 1
Atrial Perforation 1 1
Unspecified Vascular Problem 1 1
Respiratory Failure 1 1
Hypoxia 1 1
ST Segment Elevation 1 1
Low Oxygen Saturation 1 1
Myocardial Infarction 1 1
Unspecified Tissue Injury 1 1
Pulmonary Edema 1 1
Fistula 1 1
Extravasation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Nov-13-2021
2 Cook Inc. I Mar-13-2019
3 Cook Incorporated II Apr-12-2024
4 CooperSurgical, Inc. II May-01-2018
5 CooperSurgical, Inc. D.B.A. Lone Star Medical Products II Oct-29-2014
6 Ethicon Endo-Surgery Inc II Jun-26-2015
7 Instrumed International, Inc. II Dec-16-2014
8 Medical Device Technologies, Inc. II Jul-13-2010
9 Merit Medical Systems, Inc. II Mar-16-2021
10 Merit Medical Systems, Inc. II Apr-12-2016
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