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TPLC
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Device
low energy direct current thermal ablation system
Definition
Ablation of soft tissue
Product Code
OAB
Regulation Number
878.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS
SUBSTANTIALLY EQUIVALENT
1
GALVANIZE THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
US MEDICAL INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
16
16
2021
11
11
2022
4
4
2023
10
10
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
30
30
Communication or Transmission Problem
6
6
Failure of Device to Self-Test
5
5
Arcing of Electrodes
4
4
Unexpected Shutdown
4
4
Device Sensing Problem
2
2
Material Discolored
2
2
Failure to Fire
2
2
Computer Software Problem
2
2
Charging Problem
2
2
Pacing Problem
2
2
Failure to Deliver Energy
2
2
Melted
2
2
Power Problem
2
2
Device Remains Activated
2
2
Energy Output Problem
2
2
Firing Problem
2
2
No Display/Image
2
2
Output Problem
2
2
Component Misassembled
1
1
Failure to Pump
1
1
Detachment of Device or Device Component
1
1
Fracture
1
1
Failure to Calibrate
1
1
Failure to Advance
1
1
Appropriate Term/Code Not Available
1
1
Failure to Infuse
1
1
Flaked
1
1
Intermittent Loss of Power
1
1
Device Displays Incorrect Message
1
1
Delayed Charge Time
1
1
Arcing
1
1
Display or Visual Feedback Problem
1
1
No Flow
1
1
Low Sensing Threshold
1
1
Incomplete or Missing Packaging
1
1
Difficult to Open or Remove Packaging Material
1
1
Off-Label Use
1
1
Break
1
1
Mechanical Problem
1
1
No Visual Prompts/Feedback
1
1
Migration or Expulsion of Device
1
1
Material Opacification
1
1
Material Puncture/Hole
1
1
Inability to Irrigate
1
1
Wireless Communication Problem
1
1
Difficult to Advance
1
1
Insufficient Information
1
1
Unexpected Therapeutic Results
1
1
Complete Loss of Power
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
No Known Impact Or Consequence To Patient
7
7
Fistula
6
6
Thrombosis/Thrombus
5
5
Tissue Breakdown
3
3
Patient Problem/Medical Problem
2
2
Arrhythmia
2
2
Necrosis
2
2
Obstruction/Occlusion
2
2
Atrial Fibrillation
2
2
Tachycardia
2
2
Hemorrhage/Bleeding
2
2
Sepsis
1
1
Embolism/Embolus
1
1
Movement Disorder
1
1
Ventricular Fibrillation
1
1
Burn(s)
1
1
Paresis
1
1
Fluid Discharge
1
1
Heart Failure/Congestive Heart Failure
1
1
Bradycardia
1
1
Perforation of Vessels
1
1
Nodule
1
1
Tissue Damage
1
1
Aneurysm
1
1
Ulcer
1
1
No Consequences Or Impact To Patient
1
1
Bacterial Infection
1
1
Internal Organ Perforation
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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