TPLC - Total Product Life Cycle

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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

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
Unexpected Shutdown	4	4
Arcing of Electrodes	4	4
Failure to Fire	2	2
Device Sensing Problem	2	2
Charging Problem	2	2
Material Discolored	2	2
Computer Software Problem	2	2
Pacing Problem	2	2
Energy Output Problem	2	2
Power Problem	2	2
Output Problem	2	2
Melted	2	2
No Display/Image	2	2
Firing Problem	2	2
Failure to Deliver Energy	2	2
Device Remains Activated	2	2
Delayed Charge Time	1	1
Low Sensing Threshold	1	1
Tear, Rip or Hole in Device Packaging	1	1
Component Misassembled	1	1
Intermittent Loss of Power	1	1
Detachment of Device or Device Component	1	1
Labelling, Instructions for Use or Training Problem	1	1
Display or Visual Feedback Problem	1	1
Failure to Pump	1	1
Failure to Auto Stop	1	1
Poor Quality Image	1	1
Unintended Electrical Shock	1	1
Pumping Problem	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Device Damaged Prior to Use	1	1
Intermittent Energy Output	1	1
Visual Prompts will not Clear	1	1
Material Fragmentation	1	1
Stretched	1	1
Flaked	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Battery Problem	1	1
Shipping Damage or Problem	1	1
Misfire	1	1
Use of Device Problem	1	1
Failure to Power Up	1	1
Device Displays Incorrect Message	1	1
Inaccurate Synchronization	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	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
Atrial Fibrillation	2	2
Obstruction/Occlusion	2	2
Tachycardia	2	2
Hemorrhage/Bleeding	2	2
Sepsis	1	1
Embolism/Embolus	1	1
Movement Disorder	1	1
Burn(s)	1	1
Ventricular Fibrillation	1	1
Paresis	1	1
Bradycardia	1	1
Fluid Discharge	1	1
Heart Failure/Congestive Heart Failure	1	1
Perforation of Vessels	1	1
Nodule	1	1
Aneurysm	1	1
Tissue Damage	1	1
Ulcer	1	1
Bacterial Infection	1	1
No Consequences Or Impact To Patient	1	1
Internal Organ Perforation	1	1
Urinary Tract Infection	1	1