• 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 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 1
ATRICURE, INC
  SUBSTANTIALLY EQUIVALENT 3
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 49 49
2020 37 37
2021 63 63
2022 59 59
2023 99 99
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 233 233
Break 13 13
Material Deformation 11 11
Material Separation 9 9
Detachment of Device or Device Component 7 7
Material Puncture/Hole 6 6
Malposition of Device 4 4
Use of Device Problem 4 4
Material Fragmentation 4 4
No Flow 3 3
Insufficient Information 3 3
Positioning Problem 2 2
Separation Problem 2 2
High impedance 2 2
Fracture 2 2
Off-Label Use 2 2
Insufficient Flow or Under Infusion 2 2
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Smoking 1 1
Overheating of Device 1 1
Crack 1 1
Positioning Failure 1 1
Fire 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Arrhythmia 42 42
Stroke/CVA 25 25
Hemorrhage/Bleeding 24 24
Cardiac Perforation 23 23
Pericardial Effusion 18 18
Blood Loss 14 14
Perforation 14 14
Tachycardia 13 13
Anemia 12 12
Death 10 10
Cardiac Arrest 9 9
Great Vessel Perforation 8 8
Pleural Effusion 8 8
Low Blood Pressure/ Hypotension 7 7
Bradycardia 7 7
No Consequences Or Impact To Patient 7 7
Cardiac Tamponade 7 7
Respiratory Failure 6 6
Atrial Fibrillation 6 6
Fistula 5 5
Complete Heart Block 5 5
Heart Block 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Swelling/ Edema 4 4
No Known Impact Or Consequence To Patient 4 4
Myocardial Infarction 4 4
Atrial Flutter 3 3
Shock 3 3
Pulmonary Edema 3 3
Perforation of Vessels 3 3
No Patient Involvement 3 3
Extubate 3 3
Low Oxygen Saturation 3 3
Lactate Dehydrogenase Increased 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Perforation of Esophagus 2 2
Hernia 2 2
Vascular Dissection 2 2
Tissue Damage 2 2
Ulceration 2 2
Sepsis 2 2
Pulmonary Embolism 2 2
Dyspnea 2 2
Embolism 1 1
Hematoma 1 1
Inflammation 1 1
Burn(s) 1 1
Chest Pain 1 1
Pneumothorax 1 1
Pulmonary Valve Stenosis 1 1
Renal Failure 1 1
ST Segment Elevation 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Transient Ischemic Attack 1 1
Visual Impairment 1 1
Dizziness 1 1
Dysphasia 1 1
No Code Available 1 1
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Foreign Body In Patient 1 1
Ulcer 1 1
Injury 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Hematemesis 1 1
Melena 1 1
Unspecified Tissue Injury 1 1
Convulsion/Seizure 1 1
Ischemia Stroke 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AtriCure, Inc. II Jun-26-2019
2 AtriCure, Inc. II Feb-14-2019
3 MEDTRONIC ATS MEDICAL, INC. II Nov-25-2020
4 Medtronic Perfusion Systems II May-25-2022
5 Medtronic Perfusion Systems II Nov-19-2021
-
-