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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device low energy direct current thermal ablation system
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Ablation of soft tissue
Product CodeOAB
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GALVANIZE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
US MEDICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 11 11
2022 4 4
2023 10 10
2024 14 14
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Arcing of Electrodes 7 7
Failure of Device to Self-Test 4 4
Communication or Transmission Problem 4 4
Unexpected Shutdown 4 4
Power Problem 3 3
Failure to Deliver Energy 3 3
Computer Software Problem 3 3
Output Problem 2 2
Device Sensing Problem 2 2
No Display/Image 2 2
Material Discolored 2 2
Charging Problem 2 2
Failure to Fire 2 2
Melted 2 2
Energy Output Problem 2 2
Device Remains Activated 2 2
Pacing Problem 2 2
Firing Problem 2 2
Material Twisted/Bent 1 1
No Flow 1 1
Output below Specifications 1 1
Packaging Problem 1 1
Pumping Problem 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Wireless Communication Problem 1 1
Migration 1 1
Component Misassembled 1 1
Material Too Soft/Flexible 1 1
Complete Loss of Power 1 1
Intermittent Loss of Power 1 1
Unintended Electrical Shock 1 1
No Visual Prompts/Feedback 1 1
Intermittent Energy Output 1 1
Failure to Calibrate 1 1
Failure to Advance 1 1
Misfire 1 1
Low Sensing Threshold 1 1
Arcing 1 1
Delayed Charge Time 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Battery Problem 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Fistula 9 9
No Known Impact Or Consequence To Patient 5 5
Thrombosis/Thrombus 5 5
Tissue Breakdown 3 3
Atrial Fibrillation 2 2
Hemorrhage/Bleeding 2 2
Patient Problem/Medical Problem 2 2
Necrosis 2 2
Tachycardia 2 2
Aneurysm 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Burn(s) 1 1
Ulcer 1 1
Dysuria 1 1
Fluid Discharge 1 1
Movement Disorder 1 1
Embolism/Embolus 1 1
Heart Failure/Congestive Heart Failure 1 1
Internal Organ Perforation 1 1
Pain 1 1
Paresis 1 1
Sepsis 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Nodule 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Apr-12-2023
2 Angiodynamics, Inc. II Oct-07-2021
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