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	466	470
Break	243	243
Failure to Deliver Energy	221	221
Adverse Event Without Identified Device or Use Problem	214	214
Detachment of Device or Device Component	106	106
Material Twisted/Bent	56	57
Material Deformation	56	56
Retraction Problem	56	57
Difficult to Open or Close	55	55
Entrapment of Device	52	52
Mechanical Problem	50	50
Electrical /Electronic Property Problem	47	47
Device-Device Incompatibility	41	41
Use of Device Problem	31	31
Failure to Conduct	25	26
Device Contamination with Chemical or Other Material	20	20
Off-Label Use	17	17
Deformation Due to Compressive Stress	16	17
Material Split, Cut or Torn	16	16
Positioning Problem	13	13
Device Dislodged or Dislocated	13	13
Defective Device	13	13
Unsealed Device Packaging	12	12
Device Contaminated During Manufacture or Shipping	12	12
Failure to Fold	11	11
Difficult to Remove	9	9
Difficult to Advance	9	9
Material Separation	7	7
Nonstandard Device	6	6
Fracture	5	5
Human-Device Interface Problem	5	5
Failure to Fire	5	5
Material Integrity Problem	5	5
Device Handling Problem	5	5
Activation Problem	4	4
Physical Resistance/Sticking	3	3
Insufficient Information	3	3
Improper or Incorrect Procedure or Method	3	3
Dull, Blunt	3	3
Failure to Align	3	3
Tear, Rip or Hole in Device Packaging	2	2
Contamination	2	2
Crack	2	2
Appropriate Term/Code Not Available	2	2
Therapeutic or Diagnostic Output Failure	2	2
Difficult or Delayed Separation	2	2
Mechanical Jam	2	2
Optical Problem	2	2
Output Problem	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1113	1115
Hemorrhage/Bleeding	109	112
Perforation	36	36
Insufficient Information	27	28
Pancreatitis	16	16
Unspecified Tissue Injury	13	13
No Consequences Or Impact To Patient	11	11
Abdominal Pain	8	8
Gastrointestinal Hemorrhage	6	7
Bowel Perforation	6	6
Pain	5	5
Foreign Body In Patient	5	5
Device Embedded In Tissue or Plaque	4	4
No Patient Involvement	4	4
Fever	4	4
Burn(s)	4	4
Electric Shock	4	4
Stenosis	3	3
Peritonitis	2	2
Bowel Burn	2	2
Inflammation	2	2
Hematoma	2	2
Unspecified Hepatic or Biliary Problem	2	2
Unspecified Gastrointestinal Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Known Impact Or Consequence To Patient	1	1
Myocarditis	1	1
Chest Pain	1	1
Diarrhea	1	1
Discomfort	1	1
Sepsis	1	1
Pneumonia	1	1
Renal Failure	1	1
Swelling/ Edema	1	1
Unspecified Heart Problem	1	1
Unspecified Respiratory Problem	1	1
Melena	1	1
Bacterial Infection	1	1
Cancer	1	1
Tissue Breakdown	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