TPLC - Total Product Life Cycle

show TPLC since

Device	system, ablation, microwave 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	242	242
Detachment of Device or Device Component	157	157
Appropriate Term/Code Not Available	125	125
Break	95	95
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
Gas/Air Leak	8	8
Use of Device Problem	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
Therapeutic or Diagnostic Output Failure	3	3
Failure to Deliver Energy	3	3
Difficult to Remove	3	3
Biocompatibility	3	3
Visual Prompts will not Clear	3	3
Material Discolored	3	3
Fluid/Blood Leak	3	3
Output Problem	3	3
Failure to Read Input Signal	3	3
Protective Measures Problem	3	3
Insufficient Heating	3	3
Smoking	2	2
Pumping Problem	2	2
Material Fragmentation	2	2
Failure to Power Up	2	2
Device Markings/Labelling Problem	2	2
Continuous Firing	2	2
Peeled/Delaminated	2	2
Crack	2	2
Delivered as Unsterile Product	2	2
Flaked	2	2
Entrapment of Device	2	2
No Display/Image	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	121	121
Insufficient Information	73	73
Foreign Body In Patient	63	63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Pneumothorax	49	49
Hemorrhage/Bleeding	40	40
Pain	31	31
Pleural Effusion	27	27
Abscess	25	25
No Code Available	24	24
Hematoma	23	23
No Consequences Or Impact To Patient	21	21
Burn(s)	20	20
Unspecified Tissue Injury	15	15
Obstruction/Occlusion	14	14
High Blood Pressure/ Hypertension	12	12
Fistula	12	12
Abdominal Pain	11	11
Thrombosis/Thrombus	10	10
No Known Impact Or Consequence To Patient	10	10
Hypersensitivity/Allergic reaction	8	8
Full thickness (Third Degree) Burn	7	7
Unspecified Infection	7	7
Unintended Radiation Exposure	7	7
Chest Pain	6	6
Hemothorax	6	6
Fever	6	6
Radiation Exposure, Unintended	6	6
Bacterial Infection	6	6
No Information	5	5
Unspecified Hepatic or Biliary Problem	5	5
Embolism/Embolus	5	5
Sepsis	5	5
Cancer	5	5
Urinary Retention	4	4
Hemoptysis	4	4
Death	4	4
Fatigue	4	4
Peritonitis	4	4
Renal Failure	3	3
Pneumonia	3	3
Aspiration Pneumonitis	3	3
Nerve Damage	3	3
Vomiting	3	3
Pulmonary Embolism	3	3
Anemia	3	3
Perforation	3	3
Bowel Perforation	3	3
Post Operative Wound Infection	2	2