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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
Regulation Description Electrosurgical cutting and coagulation device and accessories.
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 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 63 63
2022 59 60
2023 99 99
2024 59 59
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 223 224
Break 21 21
Material Deformation 20 20
Obstruction of Flow 14 14
Material Puncture/Hole 10 10
Use of Device Problem 8 8
Material Separation 8 8
Crack 7 7
Detachment of Device or Device Component 7 7
High impedance 5 5
Malposition of Device 4 4
Separation Problem 3 3
Positioning Problem 3 3
Material Fragmentation 3 3
Fluid/Blood Leak 3 3
Mechanical Problem 2 2
Insufficient Information 2 2
Fracture 2 2
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 84 84
Arrhythmia 55 56
Cardiac Perforation 37 37
Hemorrhage/Bleeding 21 21
Stroke/CVA 20 20
Tachycardia 18 18
Hernia 11 11
Perforation 10 10
Cardiac Arrest 9 9
Great Vessel Perforation 8 8
Pericardial Effusion 7 7
Low Blood Pressure/ Hypotension 6 6
Heart Block 6 6
Anemia 6 6
Atrial Fibrillation 6 6
Bradycardia 6 6
Fistula 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cardiac Tamponade 5 5
Foreign Body In Patient 5 5
Pulmonary Embolism 3 3
Low Oxygen Saturation 3 3
Atrial Flutter 3 3
Myocardial Infarction 3 3
Swelling/ Edema 3 3
Perforation of Vessels 3 3
Shock 3 3
Pulmonary Edema 3 3
Lactate Dehydrogenase Increased 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Vomiting 3 3
Pleural Effusion 3 3
Transient Ischemic Attack 3 3
Chest Pain 2 2
Discomfort 2 2
Burn(s) 2 2
Dyspnea 2 2
Muscle Weakness 2 2
Hematoma 2 2
Sepsis 2 2
Abdominal Pain 2 2
Pulmonary Valve Stenosis 1 1
Ventricular Fibrillation 1 1
Visual Impairment 1 1
Hematemesis 1 1
No Known Impact Or Consequence To Patient 1 1
Pneumonia 1 1
Dysphagia/ Odynophagia 1 1
Obstruction/Occlusion 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Perfusion Systems II May-25-2022
2 Medtronic Perfusion Systems II Nov-19-2021
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