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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 2
ATRICURE, INC
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 37 37
2021 63 63
2022 59 59
2023 99 99
2024 59 59
2025 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 251 251
Break 23 23
Material Deformation 20 20
Obstruction of Flow 13 13
Material Puncture/Hole 10 10
Material Separation 10 10
Use of Device Problem 8 8
Detachment of Device or Device Component 8 8
Crack 6 6
High impedance 5 5
Malposition of Device 4 4
Separation Problem 3 3
Material Fragmentation 3 3
Mechanical Problem 2 2
Insufficient Information 2 2
Positioning Problem 2 2
Fracture 2 2
Fluid/Blood Leak 2 2
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Device Handling Problem 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 57 57
Cardiac Perforation 35 35
Hemorrhage/Bleeding 24 24
Stroke/CVA 23 23
Tachycardia 18 18
Perforation 13 13
Pericardial Effusion 12 12
Hernia 11 11
Anemia 9 9
Cardiac Arrest 9 9
Great Vessel Perforation 8 8
Low Blood Pressure/ Hypotension 7 7
Cardiac Tamponade 7 7
Bradycardia 7 7
Pleural Effusion 7 7
Fistula 6 6
Heart Block 6 6
Atrial Fibrillation 6 6
Blood Loss 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Myocardial Infarction 4 4
Swelling/ Edema 4 4
Foreign Body In Patient 4 4
Pulmonary Embolism 3 3
Respiratory Failure 3 3
Low Oxygen Saturation 3 3
Atrial Flutter 3 3
Extubate 3 3
No Consequences Or Impact To Patient 3 3
Vascular Dissection 3 3
Perforation of Vessels 3 3
Transient Ischemic Attack 3 3
Shock 3 3
Pulmonary Edema 3 3
Lactate Dehydrogenase Increased 3 3
Dyspnea 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Vomiting 3 3
Discomfort 2 2
Chest Pain 2 2
Burn(s) 2 2
No Known Impact Or Consequence To Patient 2 2
Muscle Weakness 2 2
Hematoma 2 2
Sepsis 2 2
Abdominal Pain 2 2
Pulmonary Valve Stenosis 1 1
Insufficient Information 1 1
Visual Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDTRONIC ATS MEDICAL, INC. II Nov-25-2020
2 Medtronic Perfusion Systems II May-25-2022
3 Medtronic Perfusion Systems II Nov-19-2021
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