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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Definition Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Product CodeOCL
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE INC.
  SUBSTANTIALLY EQUIVALENT 2
ATRICURE, INC
  SUBSTANTIALLY EQUIVALENT 3
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 9
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NCONTACT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 15 15
2015 31 31
2016 76 76
2017 55 55
2018 61 61
2019 49 49
2020 37 37
2021 63 63
2022 59 59
2023 99 99
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 402 402
Detachment Of Device Component 42 42
Break 17 17
Detachment of Device or Device Component 15 15
Material Deformation 14 14
Failure To Adhere Or Bond 14 14
Device Dislodged or Dislocated 11 11
Material Separation 10 10
Insufficient Information 8 8
Material Fragmentation 7 7
Use of Device Problem 7 7
Material Puncture/Hole 6 6
Device Handling Problem 5 5
Fracture 4 4
Malposition of Device 4 4
No Flow 3 3
Positioning Problem 3 3
Material Integrity Problem 3 3
Device Operates Differently Than Expected 3 3
Separation Problem 3 3
Device Inoperable 2 2
Device Displays Incorrect Message 2 2
Insufficient Flow or Under Infusion 2 2
Loss of or Failure to Bond 2 2
Off-Label Use 2 2
High impedance 2 2
Migration or Expulsion of Device 2 2
Overheating of Device 1 1
Failure to Power Up 1 1
Mechanical Problem 1 1
Smoking 1 1
Inadequate or Insufficient Training 1 1
Crack 1 1
Positioning Failure 1 1
Material Discolored 1 1
No Display/Image 1 1
Energy Output To Patient Tissue Incorrect 1 1
Fire 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Improper or Incorrect Procedure or Method 1 1
Material Protrusion/Extrusion 1 1
Gas/Air Leak 1 1
Human Factors Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stroke/CVA 63 63
No Known Impact Or Consequence To Patient 50 50
No Clinical Signs, Symptoms or Conditions 48 48
Arrhythmia 48 48
Death 45 45
Pericardial Effusion 33 33
Hemorrhage/Bleeding 28 28
No Consequences Or Impact To Patient 27 27
Cardiac Perforation 27 27
Blood Loss 25 25
Perforation 23 23
Hernia 19 19
Thrombus 19 19
Tissue Damage 15 15
Cardiac Tamponade 13 13
Tachycardia 13 13
Fistula 12 12
Anemia 12 12
Pleural Effusion 11 11
Great Vessel Perforation 11 11
Perforation of Esophagus 9 9
Low Blood Pressure/ Hypotension 9 9
Cardiac Arrest 9 9
Bradycardia 8 8
Complete Heart Block 8 8
Respiratory Failure 6 6
No Information 6 6
Atrial Fibrillation 6 6
Transient Ischemic Attack 6 6
Pulmonary Embolism 5 5
Inflammation 5 5
Nerve Damage 5 5
Foreign Body In Patient 5 5
Heart Block 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Swelling/ Edema 4 4
Injury 4 4
No Patient Involvement 4 4
Myocardial Infarction 4 4
Sepsis 4 4
Perforation of Vessels 4 4
Shock 3 3
Vomiting 3 3
Pulmonary Edema 3 3
Pulmonary Valve Stenosis 3 3
Extubate 3 3
Ischemia 3 3
Abdominal Pain 3 3
Air Embolism 3 3
Atrial Flutter 3 3
Dyspnea 3 3
Chest Pain 3 3
Low Oxygen Saturation 3 3
Lactate Dehydrogenase Increased 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Vascular Dissection 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Infarction, Cerebral 2 2
Burn(s) 2 2
Nausea 2 2
Paralysis 2 2
Pneumonia 2 2
Pneumothorax 2 2
Discomfort 2 2
Renal Failure 2 2
ST Segment Elevation 2 2
Ulceration 2 2
Ventricular Fibrillation 2 2
Visual Impairment 2 2
Visual Disturbances 1 1
Weakness 1 1
Blurred Vision 1 1
Ventricular Flutter 1 1
Ventricular Tachycardia 1 1
Excessive Tear Production 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Dizziness 1 1
Dysphasia 1 1
Heart Failure 1 1
Viral Infection 1 1
Stenosis 1 1
Ulcer 1 1
Unspecified Infection 1 1
Hematoma 1 1
Hemothorax 1 1
Congestive Heart Failure 1 1
Embolism 1 1
Dysphagia/ Odynophagia 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Partial thickness (Second Degree) Burn 1 1
Low Cardiac Output 1 1
Thromboembolism 1 1
Alteration In Body Temperature 1 1
Insufficient Information 1 1
Hematemesis 1 1
Melena 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AtriCure, Inc. II Jun-26-2019
2 AtriCure, Inc. II Feb-14-2019
3 AtriCure, Inc. II Nov-22-2016
4 Atricure Inc II Mar-06-2013
5 Cardima Inc II Sep-27-2010
6 MEDTRONIC ATS MEDICAL, INC. II Nov-25-2020
7 Medtronic Perfusion Systems II May-25-2022
8 Medtronic Perfusion Systems II Nov-19-2021
9 St. Jude Medical Atrial Fibrillation Division Inc II Jun-07-2010
10 St. Jude Medical Inc II Jan-30-2009
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