TPLC - Total Product Life Cycle

• Device: snare, flexible
• 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
FINEMEDIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INCORE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIGENT ENDOSCOPY
	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
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	135	135
2020	487	487
2021	211	211
2022	246	246
2023	209	209
2024	161	161

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	542	542
Break	236	236
Failure to Deliver Energy	188	188
Unsealed Device Packaging	142	142
Adverse Event Without Identified Device or Use Problem	119	119
Entrapment of Device	105	105
Detachment of Device or Device Component	101	101
Retraction Problem	78	78
Difficult to Open or Close	64	64
Electrical /Electronic Property Problem	63	63
Material Deformation	48	48
Material Twisted/Bent	45	45
Defective Device	42	42
Mechanical Problem	37	37
Device Contamination with Chemical or Other Material	36	36
Positioning Problem	36	36
Device-Device Incompatibility	35	35
Use of Device Problem	20	20
Material Split, Cut or Torn	16	16
Device Dislodged or Dislocated	14	14
Human-Device Interface Problem	13	13
Difficult to Advance	12	12
Appropriate Term/Code Not Available	11	11
Failure to Fold	10	10
Failure to Conduct	9	9
Off-Label Use	7	7
Difficult to Remove	7	7
Material Separation	5	5
Fracture	5	5
Therapeutic or Diagnostic Output Failure	5	5
Failure to Advance	5	5
Device Contaminated During Manufacture or Shipping	4	4
Device Markings/Labelling Problem	4	4
Insufficient Information	3	3
Physical Resistance/Sticking	3	3
Material Integrity Problem	3	3
Positioning Failure	3	3
Failure to Align	3	3
Tear, Rip or Hole in Device Packaging	2	2
Failure to Fire	2	2
Improper or Incorrect Procedure or Method	2	2
Device Handling Problem	2	2
Deformation Due to Compressive Stress	2	2
Device Difficult to Setup or Prepare	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Device Emits Odor	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Material Protrusion/Extrusion	1	1
Structural Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	698	698
No Consequences Or Impact To Patient	351	351
No Patient Involvement	133	133
Hemorrhage/Bleeding	107	107
No Known Impact Or Consequence To Patient	65	65
Perforation	38	38
Tissue Damage	22	22
No Code Available	19	19
Insufficient Information	18	18
Unspecified Tissue Injury	11	11
Hematoma	9	9
Abdominal Pain	8	8
Bowel Perforation	6	6
Foreign Body In Patient	6	6
Pancreatitis	6	6
Burn(s)	5	5
Fever	4	4
Stenosis	4	4
Pain	3	3
Electric Shock	3	3
Peritonitis	2	2
Gastrointestinal Hemorrhage	2	2
Unspecified Hepatic or Biliary Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Device Embedded In Tissue or Plaque	2	2
Inflammation	1	1
Abrasion	1	1
Burn, Thermal	1	1
Bowel Burn	1	1
No Information	1	1
Discomfort	1	1
Diarrhea	1	1
Chest Pain	1	1
Pneumonia	1	1
Shock	1	1
Renal Failure	1	1
Swelling/ Edema	1	1
Unspecified Heart Problem	1	1
Unspecified Respiratory Problem	1	1
Melena	1	1
Cancer	1	1
Bacterial Infection	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