TPLC - Total Product Life Cycle

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Device	snare, flexible
Regulation Description	Endoscopic electrosurgical unit and accessories.
Product Code	FDI
Regulation Number	876.4300
Device Class	2

Premarket Reviews
Manufacturer	Decision
BEIJING ZKSK TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INCORE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	539	540
Break	252	252
Failure to Deliver Energy	233	233
Adverse Event Without Identified Device or Use Problem	222	222
Detachment of Device or Device Component	111	111
Retraction Problem	70	71
Entrapment of Device	55	55
Mechanical Problem	55	55
Material Deformation	54	54
Material Twisted/Bent	54	55
Electrical /Electronic Property Problem	50	50
Difficult to Open or Close	48	48
Device-Device Incompatibility	41	41
Positioning Problem	39	39
Use of Device Problem	32	32
Failure to Conduct	26	27
Device Contamination with Chemical or Other Material	20	20
Off-Label Use	17	17
Deformation Due to Compressive Stress	16	16
Material Split, Cut or Torn	15	15
Unsealed Device Packaging	14	14
Device Dislodged or Dislocated	13	13
Defective Device	13	13
Device Contaminated During Manufacture or Shipping	12	12
Failure to Fold	11	11
Difficult to Advance	10	10
Difficult to Remove	9	9
Nonstandard Device	8	8
Material Separation	7	7
Material Integrity Problem	6	6
Insufficient Device Problem Information	5	5
Device Handling Problem	5	5
Failure to Fire	5	5
Fracture	5	5
Human-Device Interface Problem	5	5
Dull, Blunt	4	4
Activation Problem	4	4
Failure to Align	3	3
Improper or Incorrect Procedure or Method	3	3
Contamination	2	2
Mechanical Jam	2	2
Material Frayed	2	2
Optical Problem	2	2
Difficult or Delayed Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Crack	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Device Reprocessing Problem	2	2
Premature Activation	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1233	1235
Hemorrhage/Blood Loss/Bleeding	112	115
Perforation	37	37
Insufficient Information	28	29
Pancreatitis	16	16
Unspecified Tissue Injury	13	13
No Consequences Or Impact To Patient	11	11
Abdominal Pain	8	8
Gastrointestinal Hemorrhage	8	9
Bowel Perforation	8	8
Cholangitis	6	6
Pain	5	5
Foreign Body In Patient	5	5
Electric Shock	4	4
Device Embedded In Tissue or Plaque	4	4
Burn(s)	4	4
Fever	4	4
No Patient Involvement	4	4
Stenosis	3	3
Bowel Burn	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Unspecified Hepatic or Biliary Problem	2	2
Peritonitis	2	2
Inflammation	2	2
Hematoma	2	2
Unspecified Gastrointestinal Problem	2	2
Chest Pain	1	1
Diarrhea	1	1
Discomfort	1	1
No Known Impact Or Consequence To Patient	1	1
Myocarditis	1	1
Pneumonia	1	1
Renal Failure	1	1
Swelling/ Edema	1	1
Unspecified Heart Problem	1	1
Unspecified Respiratory Problem	1	1
Sepsis	1	1
Bacterial Infection	1	1
Cancer	1	1
Tissue Breakdown	1	1
Melena	1	1
Fistula	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Mar-04-2021
2	Olympus Corporation of the Americas	II	Nov-07-2025