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	2
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
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	275	275
Detachment of Device or Device Component	196	196
Appropriate Term/Code Not Available	129	129
Break	100	100
Temperature Problem	32	32
Leak/Splash	21	21
Device Alarm System	18	18
No Flow	15	15
Energy Output Problem	14	14
Material Twisted/Bent	12	12
Device Displays Incorrect Message	11	11
Activation Problem	11	11
Fracture	11	11
Activation, Positioning or Separation Problem	9	9
Gas/Air Leak	9	9
Insufficient Information	9	9
Use of Device Problem	8	8
Failure to Fire	8	8
Material Integrity Problem	7	7
Intermittent Energy Output	7	7
Thermal Decomposition of Device	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Connection Problem	6	6
Excessive Heating	5	5
Therapeutic or Diagnostic Output Failure	5	5
Difficult or Delayed Activation	5	5
Defective Device	4	4
Material Separation	4	4
Insufficient Heating	3	3
Protective Measures Problem	3	3
Difficult to Remove	3	3
Output Problem	3	3
Entrapment of Device	3	3
Visual Prompts will not Clear	3	3
Material Discolored	3	3
Fluid/Blood Leak	3	4
Biocompatibility	3	3
Failure to Read Input Signal	3	3
Failure to Deliver Energy	3	3
Melted	2	2
Firing Problem	2	2
Flaked	2	2
No Apparent Adverse Event	2	2
Delivered as Unsterile Product	2	2
Continuous Firing	2	2
Failure to Power Up	2	2
Material Fragmentation	2	2
Smoking	2	2
Pumping Problem	2	2
Device Markings/Labelling Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	223	223
Device Embedded In Tissue or Plaque	160	160
Insufficient Information	79	80
Foreign Body In Patient	70	70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	68	68
Pneumothorax	56	56
Hemorrhage/Bleeding	48	48
Pain	32	32
Pleural Effusion	32	32
Abscess	30	30
Hematoma	26	26
No Code Available	24	24
Burn(s)	22	22
No Consequences Or Impact To Patient	21	21
Unspecified Tissue Injury	15	15
Obstruction/Occlusion	14	14
Unspecified Infection	13	13
Fever	13	13
Fistula	13	13
Abdominal Pain	12	12
High Blood Pressure/ Hypertension	12	12
Thrombosis/Thrombus	12	12
No Known Impact Or Consequence To Patient	10	10
Hemoptysis	8	8
Hypersensitivity/Allergic reaction	8	8
Chest Pain	7	7
Full thickness (Third Degree) Burn	7	7
Unintended Radiation Exposure	7	7
Radiation Exposure, Unintended	6	6
Bacterial Infection	6	6
Renal Failure	6	6
Hemothorax	6	6
No Information	5	5
Sepsis	5	5
Embolism/Embolus	5	5
Unspecified Hepatic or Biliary Problem	5	5
Pneumonia	5	5
Cancer	5	5
Urinary Retention	4	4
Ascites	4	4
Vomiting	4	4
Peritonitis	4	4
Death	4	4
Perforation	4	4
Bone Fracture(s)	4	4
Fatigue	4	4
Aspiration Pneumonitis	3	3
Anemia	3	3
Tissue Breakdown	3	3
Intra-Abdominal Hemorrhage	3	3