TPLC - Total Product Life Cycle

show TPLC since

Device	unit, electrosurgical, endoscopic (with or without accessories)
Regulation Description	Endoscopic electrosurgical unit and accessories.
Product Code	KNS
Regulation Number	876.4300
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANREI MEDICAL (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AQUA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
BEIJING ZKSK TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
CREO MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	3
FRANCIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
G-FLEX EUROPE SPRL
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LAMIDEY NOURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD .
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SB-KAWASUMI LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
STARMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2623	2623
Adverse Event Without Identified Device or Use Problem	1609	1611
Detachment of Device or Device Component	425	425
Material Deformation	266	266
Use of Device Problem	173	173
Material Separation	167	167
Material Split, Cut or Torn	165	165
Device Dislodged or Dislocated	101	101
Positioning Problem	93	93
Peeled/Delaminated	91	91
Off-Label Use	88	88
Activation Failure	79	79
Melted	73	73
Device Contamination with Chemical or Other Material	72	72
Device Contaminated During Manufacture or Shipping	71	71
Mechanical Problem	70	70
Material Integrity Problem	69	69
Activation, Positioning or Separation Problem	66	66
Defective Device	59	59
Material Twisted/Bent	57	57
Failure to Fold	55	55
Difficult to Advance	50	50
Fracture	49	49
Material Fragmentation	48	48
Failure to Conduct	48	48
Retraction Problem	45	45
Positioning Failure	41	41
Insufficient Information	32	32
Failure to Align	30	30
Sparking	28	28
Thermal Decomposition of Device	26	26
Failure to Deliver Energy	23	23
Deformation Due to Compressive Stress	21	21
Device Displays Incorrect Message	18	18
Failure to Cut	18	18
Sharp Edges	17	17
Pressure Problem	16	16
Migration	15	15
Temperature Problem	15	15
Difficult or Delayed Activation	13	13
Tear, Rip or Hole in Device Packaging	13	13
Entrapment of Device	13	13
Electrical /Electronic Property Problem	12	12
Crack	12	12
Difficult to Remove	12	12
Device Stenosis	11	11
Improper or Incorrect Procedure or Method	10	10
Unsealed Device Packaging	10	10
Output Problem	10	10
Structural Problem	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4152	4152
Hemorrhage/Bleeding	499	500
Perforation	330	330
Urinary Retention	219	220
Hematuria	151	152
Urinary Tract Infection	135	135
Foreign Body In Patient	133	133
Pain	127	128
Insufficient Information	120	121
Micturition Urgency	111	111
Dysuria	94	95
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	83	84
Fever	81	81
Pancreatitis	80	80
Unspecified Infection	75	75
Urinary Frequency	72	72
Inflammation	66	66
Gastrointestinal Hemorrhage	66	66
Unspecified Tissue Injury	57	57
Bowel Perforation	53	53
Urinary Incontinence	48	49
Abdominal Pain	46	46
No Consequences Or Impact To Patient	45	45
Peritonitis	35	35
Sepsis	34	34
Stenosis	32	33
Internal Organ Perforation	30	30
Swelling/ Edema	29	29
Necrosis	28	28
Bacterial Infection	27	27
Discomfort	27	27
Sexual Dysfunction	26	26
Urethral Stenosis/Stricture	22	22
Hematoma	21	21
Obstruction/Occlusion	21	21
Pleural Effusion	20	20
Erectile Dysfunction	19	19
Stenosis of the esophagus	18	18
Fistula	17	17
Scar Tissue	17	17
Unspecified Hepatic or Biliary Problem	17	17
Abscess	17	17
Perforation of Esophagus	16	16
Cramp(s) /Muscle Spasm(s)	15	15
Burn(s)	13	13
Unspecified Kidney or Urinary Problem	13	13
Pneumonia	12	12
Aspiration Pneumonitis	10	10
Burning Sensation	9	9
Pneumothorax	9	9

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Boston Scientific Corporation	II	Jan-29-2025
3	Boston Scientific Corporation	II	Jul-12-2024
4	Boston Scientific Corporation	II	Apr-18-2023
5	Boston Scientific Corporation	II	Mar-11-2022
6	Olympus Corporation of the Americas	II	Sep-12-2024
7	Olympus Corporation of the Americas	II	Apr-05-2024