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
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	264	264
Detachment of Device or Device Component	174	174
Appropriate Term/Code Not Available	127	127
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
Activation Problem	11	11
Fracture	11	11
Activation, Positioning or Separation Problem	9	9
Insufficient Information	9	9
Gas/Air Leak	9	9
Failure to Fire	8	8
Use of Device Problem	8	8
Connection Problem	6	6
Intermittent Energy Output	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Material Integrity 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
Biocompatibility	3	3
Fluid/Blood Leak	3	3
Insufficient Heating	3	3
Protective Measures Problem	3	3
Material Discolored	3	3
Visual Prompts will not Clear	3	3
Difficult to Remove	3	3
Therapeutic or Diagnostic Output Failure	3	3
Failure to Deliver Energy	3	3
Failure to Read Input Signal	3	3
Output Problem	3	3
Material Fragmentation	2	2
Failure to Power Up	2	2
Smoking	2	2
Failure to Shut Off	2	2
Continuous Firing	2	2
Pumping Problem	2	2
Delivered as Unsterile Product	2	2
Device Markings/Labelling Problem	2	2
Peeled/Delaminated	2	2
Crack	2	2
Flaked	2	2
Entrapment of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	219	219
Device Embedded In Tissue or Plaque	139	139
Insufficient Information	77	77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	68	68
Foreign Body In Patient	65	65
Pneumothorax	53	53
Hemorrhage/Bleeding	43	43
Pain	32	32
Pleural Effusion	31	31
Abscess	30	30
Hematoma	26	26
No Code Available	24	24
No Consequences Or Impact To Patient	21	21
Burn(s)	21	21
Unspecified Tissue Injury	15	15
Obstruction/Occlusion	14	14
Unspecified Infection	13	13
Abdominal Pain	12	12
High Blood Pressure/ Hypertension	12	12
Fistula	12	12
Thrombosis/Thrombus	12	12
Fever	11	11
No Known Impact Or Consequence To Patient	10	10
Hypersensitivity/Allergic reaction	8	8
Unintended Radiation Exposure	7	7
Full thickness (Third Degree) Burn	7	7
Chest Pain	6	6
Bacterial Infection	6	6
Hemothorax	6	6
Hemoptysis	6	6
Radiation Exposure, Unintended	6	6
Embolism/Embolus	5	5
Pneumonia	5	5
Unspecified Hepatic or Biliary Problem	5	5
No Information	5	5
Cancer	5	5
Sepsis	5	5
Bone Fracture(s)	4	4
Perforation	4	4
Death	4	4
Vomiting	4	4
Urinary Retention	4	4
Fatigue	4	4
Peritonitis	4	4
Ascites	4	4
Renal Failure	3	3
Aspiration Pneumonitis	3	3
Nerve Damage	3	3
Nausea	3	3
Pulmonary Embolism	3	3