TPLC - Total Product Life Cycle

show TPLC since

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
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GALVANIZE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
HANGZHOU RUIDI BIOTECHNOLOGY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	20	20
Arcing of Electrodes	6	6
Failure of Device to Self-Test	4	4
Unexpected Shutdown	2	2
Communication or Transmission Problem	2	2
Computer Software Problem	2	2
Power Problem	2	2
Failure to Deliver Energy	1	1
Device Remains Activated	1	1
Failure to Read Input Signal	1	1
No Display/Image	1	1
Smoking	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Charging Problem	1	1
Device Emits Odor	1	1
Device Sensing Problem	1	1
Activation Failure	1	1
Pacing Problem	1	1
Melted	1	1
Firing Problem	1	1
Low Sensing Threshold	1	1
Arcing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	25	25
Fistula	10	10
Thrombosis/Thrombus	5	5
Necrosis	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Internal Organ Perforation	2	2
Arrhythmia	1	1
Sepsis	1	1
Dysuria	1	1
Perforation	1	1
Embolism/Embolus	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Pain	1	1
Bradycardia	1	1
Heart Failure/Congestive Heart Failure	1	1
Perforation of Vessels	1	1
Nodule	1	1
Aneurysm	1	1
Ulcer	1	1
Bacterial Infection	1	1
Tissue Breakdown	1	1
Urinary Tract Infection	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1