TPLC - Total Product Life Cycle

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Device	system, ablation, microwave and accessories
Regulation Description	Electrosurgical cutting and coagulation device and accessories.
Product Code	NEY
Regulation Number	878.4400
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
BETTERS (SUZHOU)MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BETTERS(SUZHOU) MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CANYON MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	2
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	1
CREO MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	4
EMBLATION LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EMBLATION LTD.
	SUBSTANTIALLY EQUIVALENT	1
GALIL MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HYGEA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDWAVES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIMA-PRO SCIENTIFIC INC.
	SUBSTANTIALLY EQUIVALENT	1
NANJING ECO MICROWAVE SYSTEM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
1. K201262 Microwave Therapeutic System
NANJING ECO MICROWAVE SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEUWAVE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUWAVE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	258	258
Detachment of Device or Device Component	163	163
Appropriate Term/Code Not Available	126	126
Break	96	96
Temperature Problem	30	30
Leak/Splash	21	21
Device Alarm System	17	17
No Flow	16	16
Energy Output Problem	14	14
Material Twisted/Bent	12	12
Device Displays Incorrect Message	11	11
Fracture	11	11
Activation Problem	11	11
Activation, Positioning or Separation Problem	9	9
Insufficient Information	9	9
Failure to Fire	8	8
Use of Device Problem	8	8
Gas/Air Leak	8	8
Connection Problem	6	6
Material Integrity Problem	6	6
Intermittent Energy Output	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Excessive Heating	5	5
Thermal Decomposition of Device	5	5
Difficult or Delayed Activation	5	5
Material Separation	4	4
Defective Device	4	4
Failure to Read Input Signal	3	3
Insufficient Heating	3	3
Difficult to Remove	3	3
Therapeutic or Diagnostic Output Failure	3	3
Material Discolored	3	3
Biocompatibility	3	3
Visual Prompts will not Clear	3	3
Output Problem	3	3
Protective Measures Problem	3	3
Fluid/Blood Leak	3	3
Failure to Deliver Energy	3	3
Firing Problem	2	2
Peeled/Delaminated	2	2
Crack	2	2
Failure to Power Up	2	2
Flaked	2	2
Material Fragmentation	2	2
Melted	2	2
Pumping Problem	2	2
Continuous Firing	2	2
Failure to Shut Off	2	2
Delivered as Unsterile Product	2	2
Smoking	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	217	217
Device Embedded In Tissue or Plaque	128	128
Insufficient Information	76	76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	67	67
Foreign Body In Patient	65	65
Pneumothorax	52	52
Hemorrhage/Bleeding	43	43
Pain	32	32
Pleural Effusion	31	31
Abscess	28	28
Hematoma	25	25
No Code Available	24	24
No Consequences Or Impact To Patient	21	21
Burn(s)	20	20
Unspecified Tissue Injury	15	15
Obstruction/Occlusion	14	14
Fistula	12	12
Thrombosis/Thrombus	12	12
High Blood Pressure/ Hypertension	12	12
Abdominal Pain	11	11
Unspecified Infection	11	11
Fever	11	11
No Known Impact Or Consequence To Patient	10	10
Hypersensitivity/Allergic reaction	8	8
Full thickness (Third Degree) Burn	7	7
Unintended Radiation Exposure	7	7
Hemothorax	6	6
Bacterial Infection	6	6
Radiation Exposure, Unintended	6	6
Hemoptysis	6	6
Chest Pain	6	6
Embolism/Embolus	5	5
Sepsis	5	5
No Information	5	5
Pneumonia	5	5
Unspecified Hepatic or Biliary Problem	5	5
Cancer	5	5
Peritonitis	4	4
Ascites	4	4
Urinary Retention	4	4
Fatigue	4	4
Bone Fracture(s)	4	4
Vomiting	4	4
Death	4	4
Anemia	3	3
Pulmonary Embolism	3	3
Nerve Damage	3	3
Nausea	3	3
Perforation	3	3
Renal Failure	3	3