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 Code	OCL
Regulation Number	878.4400
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	233	234
Break	27	27
Material Deformation	22	22
Obstruction of Flow	16	16
Material Puncture/Hole	10	10
Material Separation	8	8
Use of Device Problem	8	8
Detachment of Device or Device Component	7	7
Crack	7	7
High impedance	6	6
Malposition of Device	4	4
Material Fragmentation	3	3
Separation Problem	3	3
Positioning Problem	3	3
Fluid/Blood Leak	3	3
Fracture	2	2
Insufficient Device Problem Information	2	2
Mechanical Problem	2	2
Connection Problem	1	1
Positioning Failure	1	1
Tear, Rip or Hole in Device Packaging	1	1
Temperature Problem	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	93
Arrhythmia	55	56
Cardiac Perforation	41	41
Hemorrhage/Blood Loss/Bleeding	27	27
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
Atrial Fibrillation	6	6
Foreign Body In Patient	6	6
Low Blood Pressure/ Hypotension	6	6
Anemia	6	6
Bradycardia	6	6
Heart Block	6	6
Cardiac Tamponade	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Fistula	5	5
Pleural Effusion	3	3
Myocardial Infarction	3	3
Atrial Flutter	3	3
Vomiting	3	3
Perforation of Vessels	3	3
Transient Ischemic Attack	3	3
Shock	3	3
Mitral Valve Insufficiency/ Regurgitation	3	3
Lactate Dehydrogenase Increased	3	3
Swelling/ Edema	3	3
Pulmonary Embolism	3	3
Low Oxygen Saturation	3	3
Pulmonary Edema	3	3
Muscle Weakness/Atrophy	2	2
Discomfort	2	2
Abdominal Pain	2	2
Dyspnea	2	2
Ischemia Stroke	2	2
Chest Pain	2	2
Burn(s)	2	2
Hematoma	2	2
Sepsis	2	2
Device Embedded In Tissue or Plaque	2	2
Visual Impairment	1	1
Obstruction/Occlusion	1	1
Dysphasia	1	1
Insufficient Information	1	1
Convulsion/Seizure	1	1
Unspecified Heart Problem	1	1
Ulcer	1	1

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