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	4
BETTERS (SUZHOU)MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BETTERS(SUZHOU) MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
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
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	266	266
Detachment of Device or Device Component	155	155
Appropriate Term/Code Not Available	122	122
Break	101	101
Temperature Problem	52	52
Leak/Splash	22	22
Device Alarm System	20	20
No Flow	19	19
Energy Output Problem	14	14
Activation Problem	13	13
Fracture	13	13
Material Twisted/Bent	13	13
Insufficient Information	13	13
Device Displays Incorrect Message	13	13
Use of Device Problem	9	9
Gas/Air Leak	9	9
Failure to Fire	9	9
Activation, Positioning or Separation Problem	9	9
Manufacturing, Packaging or Shipping Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Connection Problem	6	6
Material Integrity Problem	5	5
Defective Device	5	5
Material Fragmentation	5	5
Difficult or Delayed Activation	5	5
Thermal Decomposition of Device	5	5
Intermittent Energy Output	5	5
Material Separation	5	5
Entrapment of Device	4	4
Computer Software Problem	4	4
Difficult to Remove	4	4
Peeled/Delaminated	4	4
Protective Measures Problem	3	3
Excessive Heating	3	3
Insufficient Heating	3	3
Failure to Read Input Signal	3	3
Failure to Deliver Energy	3	3
Material Discolored	3	3
Fluid/Blood Leak	3	3
Visual Prompts will not Clear	3	3
Biocompatibility	3	3
Output Problem	3	3
Failure to Shut Off	2	2
Firing Problem	2	2
Crack	2	2
Pumping Problem	2	2
Flaked	2	2
Improper or Incorrect Procedure or Method	2	2
Device Markings/Labelling Problem	2	2
Melted	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	208	208
Device Embedded In Tissue or Plaque	113	113
Insufficient Information	62	62
No Code Available	61	62
Foreign Body In Patient	60	60
No Consequences Or Impact To Patient	59	59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	55	55
Pneumothorax	52	52
Hemorrhage/Bleeding	38	38
Pain	32	32
Pleural Effusion	31	31
Abscess	27	27
Hematoma	25	25
Burn(s)	23	24
Radiation Exposure, Unintended	16	16
Unspecified Tissue Injury	15	15
No Known Impact Or Consequence To Patient	14	14
Obstruction/Occlusion	13	13
Abdominal Pain	12	12
Fistula	12	12
High Blood Pressure/ Hypertension	11	11
Thrombosis/Thrombus	10	10
Unspecified Infection	9	10
Chest Pain	8	8
Hypersensitivity/Allergic reaction	8	8
Fever	8	8
Full thickness (Third Degree) Burn	8	8
Blood Loss	7	7
Unintended Radiation Exposure	7	7
Death	7	7
Hemothorax	6	6
No Information	6	6
Pneumonia	6	6
Injury	6	6
Bacterial Infection	6	6
Hemoptysis	5	5
Embolism/Embolus	5	5
Unspecified Hepatic or Biliary Problem	5	5
Urinary Tract Infection	5	5
Nausea	5	5
Cancer	5	5
Embolism	4	4
Bowel Perforation	4	4
Hematuria	4	4
Peritonitis	4	4
Nerve Damage	4	4
Thrombosis	4	4
No Patient Involvement	4	4
Renal Failure	3	3
Patient Problem/Medical Problem	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics Inc. (Navilyst Medical Inc.)	II	May-31-2019
2	Angiodynamics, Inc.	II	Sep-08-2021
3	Covidien Llc	II	Nov-05-2021
4	Covidien, LLC	II	Jan-12-2023