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 Code	OCL
Regulation Number	878.4400
Device Class	2

Premarket Reviews
Manufacturer	Decision
ATRICURE INC.
	SUBSTANTIALLY EQUIVALENT	3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	409	409
Detachment Of Device Component	42	42
Break	17	17
Detachment of Device or Device Component	16	16
Material Deformation	15	15
Failure To Adhere Or Bond	14	14
Device Dislodged or Dislocated	11	11
Material Separation	10	10
Material Puncture/Hole	9	9
Insufficient Information	8	8
Material Fragmentation	7	7
Use of Device Problem	7	7
Device Handling Problem	5	5
Malposition of Device	4	4
Crack	4	4
Fracture	4	4
Device Operates Differently Than Expected	3	3
No Flow	3	3
Separation Problem	3	3
Positioning Problem	3	3
Material Integrity Problem	3	3
High impedance	2	2
Off-Label Use	2	2
Migration or Expulsion of Device	2	2
Insufficient Flow or Under Infusion	2	2
Device Inoperable	2	2
Loss of or Failure to Bond	2	2
Fluid/Blood Leak	2	2
Device Displays Incorrect Message	2	2
Material Protrusion/Extrusion	1	1
Tear, Rip or Hole in Device Packaging	1	1
Gas/Air Leak	1	1
Failure to Power Up	1	1
Obstruction of Flow	1	1
Material Discolored	1	1
Positioning Failure	1	1
Therapeutic or Diagnostic Output Failure	1	1
Smoking	1	1
Energy Output To Patient Tissue Incorrect	1	1
Improper or Incorrect Procedure or Method	1	1
Appropriate Term/Code Not Available	1	1
Overheating of Device	1	1
Inadequate or Insufficient Training	1	1
Human Factors Issue	1	1
Patient Device Interaction Problem	1	1
Mechanical Problem	1	1
No Display/Image	1	1
Fire	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Stroke/CVA	63	63
No Clinical Signs, Symptoms or Conditions	54	54
No Known Impact Or Consequence To Patient	50	50
Arrhythmia	48	48
Death	45	45
Pericardial Effusion	33	33
Hemorrhage/Bleeding	30	30
Cardiac Perforation	29	29
No Consequences Or Impact To Patient	27	27
Blood Loss	25	25
Perforation	23	23
Hernia	19	19
Thrombus	19	19
Tissue Damage	15	15
Tachycardia	14	14
Cardiac Tamponade	13	13
Fistula	12	12
Anemia	12	12
Pleural Effusion	11	11
Great Vessel Perforation	11	11
Low Blood Pressure/ Hypotension	9	9
Perforation of Esophagus	9	9
Cardiac Arrest	9	9
Bradycardia	8	8
Complete Heart Block	8	8
Transient Ischemic Attack	7	7
Pulmonary Embolism	6	6
Respiratory Failure	6	6
Heart Block	6	6
No Information	6	6
Atrial Fibrillation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Nerve Damage	5	5
Foreign Body In Patient	5	5
Inflammation	5	5
No Patient Involvement	4	4
Injury	4	4
Perforation of Vessels	4	4
Swelling/ Edema	4	4
Myocardial Infarction	4	4
Sepsis	4	4
Ischemia	3	3
Shock	3	3
Extubate	3	3
Pulmonary Edema	3	3
Chest Pain	3	3
Atrial Flutter	3	3
Pulmonary Valve Stenosis	3	3
Vomiting	3	3
Low Oxygen Saturation	3	3

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