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TPLC
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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 Code
OAB
Regulation Number
878.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
28
28
Arcing of Electrodes
7
7
Unexpected Shutdown
4
4
Failure of Device to Self-Test
4
4
Communication or Transmission Problem
4
4
Power Problem
3
3
Computer Software Problem
2
2
Failure to Deliver Energy
2
2
Melted
2
2
Energy Output Problem
2
2
Firing Problem
2
2
Material Discolored
2
2
Output Problem
2
2
Failure to Fire
2
2
Pacing Problem
2
2
Device Sensing Problem
2
2
No Display/Image
2
2
Charging Problem
2
2
Device Remains Activated
2
2
Material Fragmentation
1
1
Obstruction of Flow
1
1
Migration
1
1
Device Displays Incorrect Message
1
1
Incomplete or Missing Packaging
1
1
Failure to Calibrate
1
1
Material Integrity Problem
1
1
Connection Problem
1
1
Pumping Problem
1
1
Material Puncture/Hole
1
1
Arcing
1
1
Difficult to Advance
1
1
Device Handling Problem
1
1
Stretched
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Inability to Irrigate
1
1
Expulsion
1
1
Shipping Damage or Problem
1
1
Failure to Infuse
1
1
Insufficient Flow or Under Infusion
1
1
Unintended Electrical Shock
1
1
Packaging Problem
1
1
No Visual Prompts/Feedback
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Sparking
1
1
Use of Device Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Flaked
1
1
Failure to Power Up
1
1
Calibration Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
Fistula
7
7
Thrombosis/Thrombus
5
5
No Known Impact Or Consequence To Patient
5
5
Tissue Breakdown
3
3
Patient Problem/Medical Problem
2
2
Tachycardia
2
2
Necrosis
2
2
Atrial Fibrillation
2
2
Hemorrhage/Bleeding
2
2
Aneurysm
1
1
Embolism/Embolus
1
1
Ventricular Fibrillation
1
1
Bradycardia
1
1
Sepsis
1
1
Fluid Discharge
1
1
Nodule
1
1
Bacterial Infection
1
1
Heart Failure/Congestive Heart Failure
1
1
Burn(s)
1
1
Ulcer
1
1
Tissue Damage
1
1
Perforation of Vessels
1
1
Paresis
1
1
Internal Organ Perforation
1
1
Arrhythmia
1
1
Movement Disorder
1
1
Urinary Tract Infection
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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