TPLC - Total Product Life Cycle

• 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
BOSTON SCIENTIFIC CORPORATION
	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
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	487	489
2021	211	215
2022	246	246
2023	209	209
2024	279	279
2025	215	215

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	618	621
Break	268	268
Failure to Deliver Energy	214	214
Adverse Event Without Identified Device or Use Problem	198	198
Unsealed Device Packaging	143	143
Detachment of Device or Device Component	111	111
Entrapment of Device	94	94
Difficult to Open or Close	81	81
Retraction Problem	78	78
Electrical /Electronic Property Problem	70	70
Material Twisted/Bent	65	65
Material Deformation	58	58
Mechanical Problem	53	54
Device-Device Incompatibility	44	44
Defective Device	41	41
Positioning Problem	27	27
Use of Device Problem	27	27
Device Contamination with Chemical or Other Material	23	23
Failure to Conduct	19	19
Material Split, Cut or Torn	18	18
Device Dislodged or Dislocated	15	15
Difficult to Advance	13	13
Human-Device Interface Problem	13	13
Device Contaminated During Manufacture or Shipping	11	11
Off-Label Use	11	11
Failure to Fold	11	11
Appropriate Term/Code Not Available	11	11
Difficult to Remove	8	8
Material Separation	7	7
Failure to Advance	5	5
Fracture	5	5
Device Handling Problem	5	5
Deformation Due to Compressive Stress	4	5
Activation Problem	4	4
Device Markings/Labelling Problem	4	4
Insufficient Information	4	4
Material Integrity Problem	4	4
Therapeutic or Diagnostic Output Failure	4	5
Improper or Incorrect Procedure or Method	3	3
Failure to Fire	3	3
Failure to Align	3	3
Positioning Failure	3	3
Physical Resistance/Sticking	3	3
Device Difficult to Setup or Prepare	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Nonstandard Device	2	2
Dull, Blunt	2	2
Material Discolored	1	1
Difficult or Delayed Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	986	986
No Consequences Or Impact To Patient	264	264
Hemorrhage/Bleeding	131	134
No Patient Involvement	130	130
Perforation	43	43
No Known Impact Or Consequence To Patient	42	44
Insufficient Information	23	24
Tissue Damage	22	22
No Code Available	15	15
Pancreatitis	14	14
Unspecified Tissue Injury	12	12
Abdominal Pain	9	9
Hematoma	7	7
Gastrointestinal Hemorrhage	6	6
Bowel Perforation	6	6
Pain	6	6
Burn(s)	5	5
Foreign Body In Patient	5	5
Electric Shock	4	4
Stenosis	4	4
Fever	4	4
Device Embedded In Tissue or Plaque	2	2
Unspecified Hepatic or Biliary Problem	2	2
Peritonitis	2	2
Bowel Burn	2	2
Inflammation	2	2
Unspecified Gastrointestinal Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Myocarditis	1	1
Chest Pain	1	1
Diarrhea	1	1
Discomfort	1	1
Burn, Thermal	1	1
Pneumonia	1	1
Renal Failure	1	1
Swelling/ Edema	1	1
Sepsis	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

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Mar-04-2021
2	Boston Scientific Corporation	II	Aug-05-2020
3	Olympus Corporation of the Americas	II	Nov-07-2025