Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  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 60 60
2023 109 109
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 507 507
Break 93 93
Insufficient Information 33 33
Activation, Positioning or Separation Problem 32 32
Difficult to Insert 23 23
Fracture 13 13
Detachment of Device or Device Component 10 10
Gas/Air Leak 10 10
Unintended Movement 9 9
Material Separation 8 8
Detachment Of Device Component 7 7
Appropriate Term/Code Not Available 7 7
Device Contamination with Chemical or Other Material 6 6
Contamination /Decontamination Problem 5 5
Positioning Problem 5 5
Device Operates Differently Than Expected 5 5
Inflation Problem 5 5
Bent 5 5
Use of Device Problem 5 5
Material Fragmentation 4 4
Difficult to Advance 4 4
Physical Resistance/Sticking 4 4
Material Twisted/Bent 3 3
Component Missing 3 3
Physical Resistance 3 3
No Apparent Adverse Event 3 3
Patient Device Interaction Problem 3 3
Corroded 3 3
Difficult to Remove 3 3
Leak/Splash 3 3
Mechanical Problem 3 3
Loose or Intermittent Connection 2 2
Improper or Incorrect Procedure or Method 2 2
Unexpected Therapeutic Results 2 2
Entrapment of Device 2 2
Scratched Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 2 2
Defective Device 2 2
Failure to Advance 2 2
Device Contamination with Body Fluid 2 2
Tear, Rip or Hole in Device Packaging 2 2
Malposition of Device 2 2
Extrusion 1 1
Device-Device Incompatibility 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Device Or Device Fragments Location Unknown 1 1
Packaging Problem 1 1
Compatibility Problem 1 1
Component Misassembled 1 1
Noise, Audible 1 1
Flaked 1 1
Crack 1 1
Deflation Problem 1 1
Positioning Failure 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
Contamination 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Device Inoperable 1 1
Device Damaged Prior to Use 1 1
Material Rupture 1 1
Inadequacy of Device Shape and/or Size 1 1
Kinked 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Delivered as Unsterile Product 1 1
Unintended Collision 1 1
Particulates 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 406 406
No Known Impact Or Consequence To Patient 86 86
Pericardial Effusion 83 83
No Clinical Signs, Symptoms or Conditions 74 74
Low Blood Pressure/ Hypotension 41 41
Cardiac Tamponade 36 36
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 10 10
Hemorrhage/Bleeding 8 8
Foreign Body In Patient 7 7
No Code Available 6 6
Device Embedded In Tissue or Plaque 6 6
Thrombosis/Thrombus 6 6
Cardiac Arrest 6 6
Arrhythmia 5 5
No Information 5 5
Insufficient Information 5 5
Vascular Dissection 5 5
Air Embolism 4 4
Transient Ischemic Attack 4 4
Thrombus 3 3
Perforation of Vessels 3 3
Hemothorax 3 3
Chest Pain 3 3
Hematoma 3 3
Patient Problem/Medical Problem 3 3
Pseudoaneurysm 3 3
Needle Stick/Puncture 3 3
Aortic Dissection 2 2
Embolus 2 2
Pain 2 2
Tachycardia 2 2
Discomfort 2 2
Complaint, Ill-Defined 1 1
Injury 1 1
Extubate 1 1
Diaphoresis 1 1
Ventricular Fibrillation 1 1
Hypersensitivity/Allergic reaction 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
ST Segment Elevation 1 1
Extravasation 1 1
Fistula 1 1
Hypoxia 1 1
Myocardial Infarction 1 1
Neuropathy 1 1
Occlusion 1 1
Non specific EKG/ECG Changes 1 1
Edema 1 1
Anaphylactic Shock 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Blood Loss 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Rupture 1 1
Complete Heart Block 1 1
Superficial (First Degree) Burn 1 1
Foreign Body Embolism 1 1
Unspecified Vascular Problem 1 1
Asystole 1 1
Unspecified Tissue Injury 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
-
-