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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 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 108 108
2021 78 78
2022 61 61
2023 109 109
2024 105 105
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 277 277
Break 31 31
Difficult to Insert 28 28
Fracture 23 23
Insufficient Information 11 11
Gas/Air Leak 11 11
Unintended Movement 9 9
Material Twisted/Bent 9 9
Detachment of Device or Device Component 7 7
Material Separation 7 7
Device Contamination with Body Fluid 6 6
Difficult to Advance 4 4
Improper or Incorrect Procedure or Method 4 4
Positioning Problem 3 3
Patient Device Interaction Problem 3 3
Physical Resistance/Sticking 3 3
Corroded 3 3
Component Missing 2 2
Difficult to Remove 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 2 2
No Apparent Adverse Event 2 2
Material Protrusion/Extrusion 2 2
Obstruction of Flow 2 2
Device Contaminated During Manufacture or Shipping 2 2
Entrapment of Device 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Contamination 1 1
Failure to Disconnect 1 1
Material Fragmentation 1 1
Use of Device Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Scratched Material 1 1
Compatibility Problem 1 1
Defective Device 1 1
Device-Device Incompatibility 1 1
Malposition of Device 1 1
Failure to Advance 1 1
Structural Problem 1 1
Component Misassembled 1 1
Noise, Audible 1 1
Dull, Blunt 1 1
Particulates 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 222 222
No Clinical Signs, Symptoms or Conditions 104 104
Pericardial Effusion 41 41
Cardiac Tamponade 28 28
Low Blood Pressure/ Hypotension 19 19
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 13 13
Thrombosis/Thrombus 10 10
Great Vessel Perforation 8 8
Hemorrhage/Bleeding 7 7
Foreign Body In Patient 6 6
Perforation 6 6
Death 6 6
Stroke/CVA 6 6
Insufficient Information 5 5
Arrhythmia 5 5
Transient Ischemic Attack 4 4
Hematoma 4 4
Vascular Dissection 4 4
Air Embolism 3 3
Needle Stick/Puncture 3 3
Pseudoaneurysm 3 3
Non specific EKG/ECG Changes 2 2
Thrombus 2 2
Bradycardia 1 1
Cardiac Arrest 1 1
Atrial Fibrillation 1 1
Chest Pain 1 1
Edema 1 1
Fistula 1 1
Heart Failure/Congestive Heart Failure 1 1
Asystole 1 1
Hemothorax 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Vascular Problem 1 1
Hypoxia 1 1
Unspecified Tissue Injury 1 1
Foreign Body Embolism 1 1
Embolism/Embolus 1 1
Myocardial Infarction 1 1
Pain 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Pneumothorax 1 1
ST Segment Elevation 1 1
Scar Tissue 1 1
No Code Available 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Device Embedded In Tissue or Plaque 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Nov-13-2021
2 Cook Incorporated II Apr-12-2024
3 Merit Medical Systems, Inc. II Mar-16-2021
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