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	2
CANYON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
CREO MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	3
EMBLATION , LTD.
	SUBSTANTIALLY EQUIVALENT	1
EMBLATION LIMITED
	SUBSTANTIALLY EQUIVALENT	2
HYGEA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIMA-PRO SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANJING DEVIN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING DEWEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING ECO MICROWAVE SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	255	255
Detachment of Device or Device Component	192	192
Appropriate Device Problem Term/Code Not Available	137	137
Break	89	89
Fracture	25	25
Temperature Problem	21	21
Leak/Splash	17	17
Device Alarm System	13	13
No Flow	12	12
Device Displays Incorrect Message	12	12
Energy Output Problem	12	12
Activation Problem	10	10
Gas/Air Leak	9	9
Material Twisted/Bent	8	8
Excessive Heating	7	7
Insufficient Device Problem Information	7	7
Thermal Decomposition of Device	7	7
Activation, Positioning or Separation Problem	6	6
Intermittent Energy Output	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Material Integrity Problem	6	6
Use of Device Problem	6	6
Connection Problem	5	5
Failure to Read Input Signal	3	3
Biocompatibility	3	3
Insufficient Heating	3	3
Protective Measures Problem	3	3
Failure to Fire	3	3
Material Discolored	3	3
Failure to Power Up	3	3
Melted	2	2
No Apparent Adverse Event	2	2
Material Separation	2	2
Delivered as Unsterile Product	2	2
Visual Prompts will not Clear	2	2
Defective Device	2	2
Smoking	2	2
Pumping Problem	2	2
Peeled/Delaminated	2	2
Failure to Deliver Energy	2	2
Misassembly During Maintenance/Repair	1	1
Difficult or Delayed Activation	1	1
Device Difficult to Setup or Prepare	1	1
Material Fragmentation	1	1
Scratched Material	1	1
Migration	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
No Visual Prompts/Feedback	1	1
Failure of Device to Self-Test	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	224	224
Device Embedded In Tissue or Plaque	172	172
Insufficient Information	88	89
Foreign Body In Patient	82	82
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	60	60
Pneumothorax	59	59
Hemorrhage/Blood Loss/Bleeding	53	53
Pain	35	35
Pleural Effusion	33	33
Abscess	28	28
Hematoma	26	26
Burn(s)	20	20
Unspecified Tissue Injury	14	14
Obstruction/Occlusion	14	14
Unspecified Infection	13	13
Thrombosis/Thrombus	13	13
Fever	13	13
High Blood Pressure/ Hypertension	12	12
Fistula	12	12
Abdominal Pain	11	11
Unintended Radiation Exposure	9	9
Hypersensitivity/Allergic reaction	8	8
Chest Pain	7	7
Full thickness (Third Degree) Burn	7	7
Renal Failure	6	6
Pneumonia	6	6
Hemoptysis	6	6
Hemothorax	6	6
Unspecified Hepatic or Biliary Problem	5	5
Sepsis	5	5
Embolism/Embolus	5	5
Bacterial Infection	5	5
Cancer	5	5
Bradycardia	4	4
Pseudoaneurysm	4	4
Urinary Retention	4	4
Ascites	4	4
Peritonitis	4	4
Perforation	4	4
Bone Fracture(s)	4	4
Fatigue	4	4
Low Blood Pressure/ Hypotension	3	3
Post Operative Wound Infection	3	3
Multiple Organ Dysfunction Syndrome	3	3
Anemia	3	3
Partial thickness (Second Degree) Burn	3	3
Vomiting	3	3
Pulmonary Embolism	3	3
Laceration(s)	3	3
Nausea	3	3