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	246	246
Detachment of Device or Device Component	182	182
Appropriate Term/Code Not Available	130	130
Break	89	89
Temperature Problem	21	21
Leak/Splash	17	17
Fracture	17	17
No Flow	12	12
Energy Output Problem	12	12
Device Alarm System	11	11
Device Displays Incorrect Message	10	10
Activation Problem	10	10
Gas/Air Leak	9	9
Material Twisted/Bent	9	9
Activation, Positioning or Separation Problem	7	7
Material Integrity Problem	7	7
Intermittent Energy Output	6	6
Insufficient Information	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Thermal Decomposition of Device	6	6
Connection Problem	5	5
Excessive Heating	5	5
Use of Device Problem	5	5
Defective Device	4	4
Failure to Read Input Signal	3	3
Biocompatibility	3	3
Entrapment of Device	3	3
Insufficient Heating	3	3
Protective Measures Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Failure to Fire	3	3
Material Discolored	3	3
Fluid/Blood Leak	2	3
Melted	2	2
No Apparent Adverse Event	2	2
Material Separation	2	2
Delivered as Unsterile Product	2	2
Failure to Power Up	2	2
Visual Prompts will not Clear	2	2
Difficult to Remove	2	2
Smoking	2	2
Pumping Problem	2	2
Peeled/Delaminated	2	2
Failure to Deliver Energy	2	2
Difficult or Delayed Activation	1	1
Device Difficult to Setup or Prepare	1	1
Misassembly During Maintenance/Repair	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	214	214
Device Embedded In Tissue or Plaque	160	160
Insufficient Information	82	83
Foreign Body In Patient	66	66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	58	58
Pneumothorax	55	55
Hemorrhage/Bleeding	50	50
Pain	34	34
Pleural Effusion	32	32
Abscess	28	28
Hematoma	25	25
Burn(s)	20	20
Obstruction/Occlusion	14	14
Unspecified Tissue Injury	14	14
Thrombosis/Thrombus	13	13
Fever	13	13
Unspecified Infection	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
Pneumonia	6	6
Renal Failure	6	6
Hemoptysis	6	6
Hemothorax	6	6
Bacterial Infection	5	5
Sepsis	5	5
Embolism/Embolus	5	5
Cancer	5	5
Unspecified Hepatic or Biliary Problem	5	5
Ascites	4	4
Pseudoaneurysm	4	4
Urinary Retention	4	4
Peritonitis	4	4
Bradycardia	4	4
Fatigue	4	4
Bone Fracture(s)	4	4
Perforation	4	4
Nausea	3	3
Low Blood Pressure/ Hypotension	3	3
Anemia	3	3
Pulmonary Embolism	3	3
Vomiting	3	3
Partial thickness (Second Degree) Burn	3	3
Multiple Organ Failure	3	3
Aspiration Pneumonitis	3	3
Intra-Abdominal Hemorrhage	3	3