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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, ablation, microwave and accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeNEY
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BSD MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
COVIDEN LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 3
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRAMAR LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEUWAVE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 92 92
2016 176 176
2017 225 225
2018 107 107
2019 123 123
2020 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 242 242
Adverse Event Without Identified Device or Use Problem 121 121
Tip 89 89
Device Displays Incorrect Message 74 74
Detachment Of Device Component 69 69
Break 66 66
Detachment of Device or Device Component 65 65
Bent 49 49
Fracture 43 43
Insufficient Information 39 39
Probe 36 36
Device Operates Differently Than Expected 21 21
No Flow 19 19
Device Inoperable 14 14
Crack 13 13
Leak/Splash 11 11
Failure to Fire 10 10
Alarm, Audible 9 9
Device Alarm System 7 7
Connection Problem 6 6
Material Fragmentation 6 6
Device Dislodged or Dislocated 6 6
Overheating of Device 6 6
Component Missing 6 6
Device Stops Intermittently 5 5
Difficult or Delayed Activation 5 5
Antenna 5 5
Peeled/Delaminated 5 5
Flare or Flash 5 5
Entrapment of Device 4 4
Computer Software Problem 4 4
Device Remains Activated 4 4
Improper or Incorrect Procedure or Method 4 4
Loss of Power 4 4
Gas Leak 4 4
Difficult to Remove 4 4
Material Separation 4 4
Defective Device 4 4
Failure to Deliver Energy 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Twisted/Bent 4 4
Needle 3 3
Output Problem 3 3
Infusion or Flow Problem 3 3
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
Energy Output Problem 3 3
Shaft 2 2
Flaked 2 2
Difficult to Insert 2 2
Electrical Shorting 2 2
Material Integrity Problem 2 2
Migration or Expulsion of Device 2 2
Charred 2 2
Scanner 2 2
Failure to Power Up 2 2
Failure to Deliver 2 2
Visual Prompts will not Clear 2 2
Deformation Due to Compressive Stress 2 2
Computer Operating System Problem 2 2
Activation Problem 2 2
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Activation, Positioning or SeparationProblem 1 1
Physical Property Issue 1 1
Catheter 1 1
Device Issue 1 1
Physical Resistance 1 1
Material Puncture/Hole 1 1
Unsealed Device Packaging 1 1
Difficult To Position 1 1
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Human-Device Interface Problem 1 1
Air Leak 1 1
Cable, Electrical 1 1
Insulation 1 1
No Display/Image 1 1
No Device Output 1 1
Fluid Leak 1 1
Mechanical Problem 1 1
Impedance Problem 1 1
Improper Device Output 1 1
Positioning Problem 1 1
Power Problem 1 1
Temperature Probe 1 1
Physical Resistance/Sticking 1 1
Loose or Intermittent Connection 1 1
Delivered as Unsterile Product 1 1
Therapy Delivered to Incorrect Body Area 1 1
Insufficient Cooling 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Fiber 1 1
Thermal Decomposition of Device 1 1
Defective Component 1 1
Dull, Blunt 1 1
Failure to Advance 1 1
Failure to Obtain Sample 1 1
Failure to Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 299 299
No Consequences Or Impact To Patient 189 189
Device Embedded In Tissue or Plaque 78 78
No Code Available 75 76
Foreign Body In Patient 36 36
No Information 35 35
Pneumothorax 25 25
Burn(s) 22 23
Death 21 21
Radiation Exposure, Unintended 20 20
Blood Loss 19 19
No Patient Involvement 17 17
Pain 15 15
Injury 9 9
Hemorrhage/Bleeding 9 9
Abscess 9 9
Unspecified Infection 7 8
Pleural Effusion 7 7
Burn, Thermal 7 7
Hematoma 6 6
Fever 5 5
Fistula 5 5
Cardiac Arrest 5 5
Chest Pain 5 5
Abdominal Pain 5 5
Embolism 4 4
Hemoptysis 4 4
Pneumonia 4 4
Thrombosis 4 4
Tissue Damage 3 3
Urinary Tract Infection 3 3
Nausea 3 3
Full thickness (Third Degree) Burn 3 3
Patient Problem/Medical Problem 3 3
Test Result 2 2
Necrosis 2 2
Hemothorax 2 2
Bacterial Infection 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Respiratory Distress 2 2
Hypoesthesia 2 2
Hematuria 2 2
Bowel Perforation 2 2
Dyspnea 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 1 1
Hypovolemic Shock 1 1
Inflammation 1 1
Rash 1 1
Sepsis 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Cardiomyopathy 1 1
Cardiopulmonary Arrest 1 1
Air Embolism 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Superficial (First Degree) Burn 1 1
Ulcer 1 1
Pregnancy 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Fungal Infection 1 1
Skin Inflammation 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Ventricular Tachycardia 1 1
Hepatitis 1 1
Scar Tissue 1 1
Tachycardia 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Pseudoaneurysm 1 1
Biliary Cirrhosis 1 1
Bruise/Contusion 1 1
Death, Intrauterine Fetal 1 1
Hypoxia 1 1
Nerve Damage 1 1
Liver Damage/Dysfunction 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II May-31-2019
2 Angiodynamics, Inc. II Feb-05-2018
3 Covidien LLC II Dec-18-2018
4 Covidien LLC II Feb-09-2018
5 Covidien Medical Products (Shanghai) Manufacturing L.L.C. II Mar-17-2016
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