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	487
2021	211	211
2022	246	246
2023	209	209
2024	278	278
2025	49	49

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	556	556
Break	238	238
Failure to Deliver Energy	185	185
Adverse Event Without Identified Device or Use Problem	169	169
Unsealed Device Packaging	142	142
Detachment of Device or Device Component	100	100
Entrapment of Device	89	89
Retraction Problem	73	73
Electrical /Electronic Property Problem	68	68
Difficult to Open or Close	64	64
Material Twisted/Bent	55	55
Material Deformation	51	51
Mechanical Problem	44	44
Device-Device Incompatibility	41	41
Defective Device	39	39
Positioning Problem	25	25
Device Contamination with Chemical or Other Material	22	22
Use of Device Problem	22	22
Material Split, Cut or Torn	16	16
Failure to Conduct	16	16
Device Dislodged or Dislocated	15	15
Human-Device Interface Problem	12	12
Device Contaminated During Manufacture or Shipping	11	11
Appropriate Term/Code Not Available	11	11
Failure to Fold	11	11
Off-Label Use	10	10
Difficult to Advance	10	10
Material Separation	6	6
Failure to Advance	5	5
Difficult to Remove	5	5
Fracture	5	5
Device Markings/Labelling Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Device Handling Problem	3	3
Failure to Align	3	3
Positioning Failure	3	3
Material Integrity Problem	3	3
Insufficient Information	3	3
Physical Resistance/Sticking	3	3
Device Difficult to Setup or Prepare	2	2
Tear, Rip or Hole in Device Packaging	2	2
Failure to Fire	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Improper or Incorrect Procedure or Method	2	2
Deformation Due to Compressive Stress	2	2
Material Discolored	1	1
Impedance Problem	1	1
Unraveled Material	1	1
Material Fragmentation	1	1
Degraded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	832	832
No Consequences Or Impact To Patient	264	264
No Patient Involvement	130	130
Hemorrhage/Bleeding	128	128
No Known Impact Or Consequence To Patient	42	42
Perforation	41	41
Tissue Damage	22	22
Insufficient Information	22	22
No Code Available	15	15
Pancreatitis	14	14
Unspecified Tissue Injury	11	11
Abdominal Pain	9	9
Hematoma	7	7
Pain	5	5
Foreign Body In Patient	5	5
Burn(s)	5	5
Fever	4	4
Bowel Perforation	4	4
Stenosis	4	4
Electric Shock	3	3
Peritonitis	2	2
Inflammation	2	2
Unspecified Gastrointestinal Problem	2	2
Unspecified Hepatic or Biliary Problem	2	2
Gastrointestinal Hemorrhage	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Device Embedded In Tissue or Plaque	2	2
Burn, Thermal	1	1
Myocarditis	1	1
Bowel Burn	1	1
Sepsis	1	1
Chest Pain	1	1
Diarrhea	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

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Mar-04-2021
2	Boston Scientific Corporation	II	Aug-05-2020