TPLC - Total Product Life Cycle

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Device	hemostatic metal clip for the gi tract
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
ANREI MEDICAL (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
APOLLO ENDOSURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ZKSK TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
COOK ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
FINEMEDIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INCORE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
MIRCO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
OVESCO ENDOSCOPY AG
	SUBSTANTIALLY EQUIVALENT	3
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	2271	2271
Difficult to Open or Close	618	618
Material Separation	366	366
Adverse Event Without Identified Device or Use Problem	311	311
Premature Activation	292	292
Break	280	280
Failure to Fire	243	243
Separation Failure	242	242
Premature Separation	204	204
Use of Device Problem	147	147
Detachment of Device or Device Component	142	142
Material Deformation	89	89
Human-Device Interface Problem	82	82
Material Twisted/Bent	74	74
Positioning Failure	74	74
Entrapment of Device	68	68
Difficult or Delayed Separation	60	60
Improper or Incorrect Procedure or Method	54	54
Device Fell	38	38
Difficult to Remove	37	37
Failure to Advance	31	31
Mechanical Problem	31	31
Activation Problem	26	26
Defective Device	25	25
Device Dislodged or Dislocated	24	24
Mechanical Jam	20	20
Problem with Sterilization	18	18
Difficult to Advance	17	17
Failure to Eject	16	16
Physical Resistance/Sticking	16	16
Peeled/Delaminated	16	16
Migration	16	16
Misfire	15	15
Firing Problem	14	14
Material Fragmentation	14	14
Insufficient Information	12	12
Material Integrity Problem	9	9
Activation Failure	9	9
Unraveled Material	9	9
Nonstandard Device	8	8
Material Protrusion/Extrusion	8	8
Failure to Form Staple	7	7
Unintended Movement	7	7
Appropriate Term/Code Not Available	7	7
Failure to Deliver	7	7
Separation Problem	7	7
Failure to Disconnect	7	7
Failure to Discharge	7	7
Device Reprocessing Problem	6	6
Defective Component	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2720	2720
No Consequences Or Impact To Patient	877	877
No Known Impact Or Consequence To Patient	249	249
Hemorrhage/Bleeding	166	166
Insufficient Information	84	84
Foreign Body In Patient	70	70
Gastrointestinal Hemorrhage	61	61
Perforation	43	43
Bowel Perforation	31	31
Unspecified Tissue Injury	19	19
No Code Available	18	18
Device Embedded In Tissue or Plaque	16	16
Tissue Damage	14	14
Blood Loss	12	12
No Patient Involvement	11	11
Abdominal Pain	10	10
Laceration(s)	10	10
Peritonitis	8	8
Injury	6	6
Failure of Implant	5	5
Pain	5	5
Hematoma	5	5
Pancreatitis	4	4
Unspecified Respiratory Problem	4	4
Ulcer	4	4
Hemostasis	4	4
Obstruction/Occlusion	4	4
Internal Organ Perforation	3	3
Hyperemia	3	3
Swelling/ Edema	3	3
Stenosis	3	3
Discomfort	3	3
Vomiting	3	3
Fever	3	3
Laceration(s) of Esophagus	3	3
Inflammation	3	3
Perforation of Esophagus	3	3
Unspecified Gastrointestinal Problem	3	3
Death	3	3
Chest Pain	2	2
Abrasion	2	2
Aspiration/Inhalation	2	2
Hematemesis	2	2
No Information	2	2
Nausea	2	2
Hypersensitivity/Allergic reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Needle Stick/Puncture	1	1
Septic Shock	1	1
Adhesion(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Jun-21-2023
2	US Endoscopy Group Inc	II	Mar-13-2019