TPLC - Total Product Life Cycle

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Device	hemostatic metal clip for the gi tract
Regulation Description	Hemorrhoidal ligator.
Definition	Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Product Code	PKL
Regulation Number	876.4400
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ZKSK TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
INCORE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
MIRCO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OVESCO ENDOSCOPY AG
	SUBSTANTIALLY EQUIVALENT	2
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TAURUS ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	2178	2191
Difficult to Open or Close	860	861
Material Separation	623	623
Adverse Event Without Identified Device or Use Problem	491	492
Failure to Fire	356	356
Premature Activation	337	338
Premature Separation	287	287
Separation Failure	284	284
Break	228	229
Use of Device Problem	226	230
Detachment of Device or Device Component	129	129
Improper or Incorrect Procedure or Method	108	108
Human-Device Interface Problem	94	94
Positioning Failure	81	82
Entrapment of Device	74	74
Material Twisted/Bent	74	74
Material Deformation	70	70
Difficult or Delayed Separation	62	62
Mechanical Problem	37	37
Activation Failure	31	31
Difficult to Remove	30	30
Physical Resistance/Sticking	22	22
Defective Device	21	21
Failure to Advance	21	21
Device Dislodged or Dislocated	20	20
Mechanical Jam	19	19
Peeled/Delaminated	18	18
Failure to Eject	16	16
Difficult to Advance	13	13
Insufficient Information	13	13
Migration	13	13
Material Integrity Problem	13	13
Activation Problem	12	12
Firing Problem	11	11
Device Fell	10	10
Misfire	10	10
Unintended Movement	9	9
Nonstandard Device	9	9
Separation Problem	8	8
Failure to Disconnect	7	7
Unraveled Material	7	7
Off-Label Use	7	7
Device Reprocessing Problem	7	7
Positioning Problem	6	6
Failure to Clean Adequately	5	5
Material Fragmentation	5	5
Failure to Form Staple	5	6
Difficult or Delayed Positioning	5	5
Device Contamination with Chemical or Other Material	4	4
Appropriate Term/Code Not Available	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4082	4093
Hemorrhage/Bleeding	162	163
Bowel Perforation	106	106
Insufficient Information	93	94
Gastrointestinal Hemorrhage	67	67
Foreign Body In Patient	61	61
Unspecified Tissue Injury	51	52
Perforation	43	43
No Consequences Or Impact To Patient	31	31
Abdominal Pain	11	11
Hypersensitivity/Allergic reaction	8	8
Internal Organ Perforation	8	8
Laceration(s)	7	7
Peritonitis	7	7
Pain	6	6
Failure of Implant	5	5
Pancreatitis	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Ulcer	5	5
Perforation of Esophagus	4	4
Inflammation	4	4
Obstruction/Occlusion	4	4
Unspecified Respiratory Problem	4	4
Hematoma	3	3
Device Embedded In Tissue or Plaque	3	3
Unspecified Gastrointestinal Problem	3	3
Fever	3	3
Vomiting	3	3
Swelling/ Edema	3	3
Adhesion(s)	2	2
Laceration(s) of Esophagus	2	2
Blood Loss	2	2
Nausea	2	2
Stomach Ulceration	2	2
Chest Pain	2	2
No Patient Involvement	2	2
Wound Dehiscence	2	2
Hematemesis	2	2
Stenosis	2	2
Unspecified Infection	2	2
Low Blood Pressure/ Hypotension	1	1
Airway Obstruction	1	1
Loss of consciousness	1	1
Achalasia	1	1
Fistula	1	1
Myocardial Infarction	1	1
Urinary Tract Infection	1	1
Fluid Discharge	1	1
Discomfort	1	1
Septic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Jun-21-2023
2	Wilson-Cook Medical Inc.	II	Apr-13-2026