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 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

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