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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
Product CodeNEY
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
BETTERS (SUZHOU)MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BETTERS(SUZHOU) MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
CREO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
EMBLATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EMBLATION LTD.
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HYGEA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDWAVES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIMA-PRO SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
NANJING ECO MICROWAVE SYSTEM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NANJING ECO MICROWAVE SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 123 123
2020 128 128
2021 217 217
2022 142 142
2023 107 107
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 249 249
Detachment of Device or Device Component 132 132
Appropriate Term/Code Not Available 117 117
Break 97 97
Temperature Problem 51 51
Leak/Splash 22 22
Device Alarm System 19 19
No Flow 19 19
Energy Output Problem 14 14
Fracture 13 13
Material Twisted/Bent 13 13
Activation Problem 13 13
Insufficient Information 13 13
Device Displays Incorrect Message 12 12
Failure to Fire 9 9
Activation, Positioning or Separation Problem 9 9
Use of Device Problem 9 9
Gas/Air Leak 8 8
Therapeutic or Diagnostic Output Failure 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Difficult or Delayed Activation 5 5
Defective Device 5 5
Connection Problem 5 5
Material Separation 5 5
Material Fragmentation 5 5
Thermal Decomposition of Device 5 5
Intermittent Energy Output 5 5
Computer Software Problem 4 4
Entrapment of Device 4 4
Difficult to Remove 4 4
Peeled/Delaminated 4 4
Visual Prompts will not Clear 3 3
Failure to Deliver Energy 3 3
Fluid/Blood Leak 3 3
Insufficient Heating 3 3
Material Discolored 3 3
Biocompatibility 3 3
Material Integrity Problem 3 3
Output Problem 3 3
Excessive Heating 3 3
Protective Measures Problem 2 2
Pumping Problem 2 2
Firing Problem 2 2
Failure to Shut Off 2 2
Delivered as Unsterile Product 2 2
No Display/Image 2 2
Continuous Firing 2 2
Crack 2 2
Melted 2 2
Flaked 2 2
Component Missing 2 2
Failure to Read Input Signal 2 2
Improper or Incorrect Procedure or Method 2 2
Dull, Blunt 1 1
Misfire 1 1
Device Damaged Prior to Use 1 1
Pitted 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Therapy Delivered to Incorrect Body Area 1 1
Device Remains Activated 1 1
Self-Activation or Keying 1 1
Output above Specifications 1 1
Overheating of Device 1 1
Poor Quality Image 1 1
Display or Visual Feedback Problem 1 1
Loss of or Failure to Bond 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Unexpected Shutdown 1 1
No Apparent Adverse Event 1 1
Wireless Communication Problem 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Scratched Material 1 1
Power Problem 1 1
Output below Specifications 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 196 196
Device Embedded In Tissue or Plaque 91 91
No Code Available 61 62
Insufficient Information 61 61
No Consequences Or Impact To Patient 59 59
Foreign Body In Patient 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Pneumothorax 48 48
Hemorrhage/Bleeding 34 34
Pain 31 31
Abscess 26 26
Pleural Effusion 25 25
Hematoma 24 24
Burn(s) 21 22
Radiation Exposure, Unintended 16 16
No Known Impact Or Consequence To Patient 14 14
Unspecified Tissue Injury 14 14
Obstruction/Occlusion 13 13
Abdominal Pain 12 12
Fistula 11 11
High Blood Pressure/ Hypertension 10 10
Unspecified Infection 9 10
Thrombosis/Thrombus 9 9
Full thickness (Third Degree) Burn 8 8
Hypersensitivity/Allergic reaction 8 8
Chest Pain 8 8
Death 7 7
Fever 7 7
Blood Loss 7 7
Unintended Radiation Exposure 7 7
No Information 6 6
Bacterial Infection 6 6
Injury 6 6
Pneumonia 6 6
Nausea 5 5
Urinary Tract Infection 5 5
Cancer 5 5
Embolism/Embolus 5 5
No Patient Involvement 4 4
Bowel Perforation 4 4
Peritonitis 4 4
Hematuria 4 4
Nerve Damage 4 4
Thrombosis 4 4
Embolism 4 4
Hemoptysis 4 4
Hemothorax 3 3
Renal Failure 3 3
Sepsis 3 3
Necrosis 3 3
Burn, Thermal 3 3
Patient Problem/Medical Problem 3 3
Vomiting 3 3
Aspiration Pneumonitis 3 3
Unspecified Hepatic or Biliary Problem 3 3
Swelling/ Edema 2 2
Intra-Abdominal Hemorrhage 2 2
Pseudoaneurysm 2 2
Post Operative Wound Infection 2 2
Hypoesthesia 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Internal Organ Perforation 2 2
Tachycardia 2 2
Urinary Retention 2 2
Bone Fracture(s) 2 2
Low Blood Pressure/ Hypotension 2 2
Laceration(s) 2 2
Fatigue 2 2
Awareness during Anaesthesia 2 2
Pulmonary Embolism 2 2
Wound Dehiscence 1 1
Air Embolism 1 1
Aspiration/Inhalation 1 1
Biliary Cirrhosis 1 1
Bradycardia 1 1
Dyspnea 1 1
Cardiac Arrest 1 1
Cardiomyopathy 1 1
Cardiopulmonary Arrest 1 1
Ischemia 1 1
Hypovolemic Shock 1 1
Hepatitis 1 1
Hyperemia 1 1
Tissue Damage 1 1
Ulceration 1 1
Septic Shock 1 1
Skin Irritation 1 1
Perforation 1 1
Hernia 1 1
Ventricular Tachycardia 1 1
Ulcer 1 1
Urinary Frequency 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Electric Shock 1 1
Ascites 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Vascular Dissection 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II May-31-2019
2 Angiodynamics, Inc. II Sep-08-2021
3 Covidien Llc II Nov-05-2021
4 Covidien, LLC II Jan-12-2023
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