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	2124	2124
Difficult to Open or Close	531	531
Material Separation	290	290
Break	271	271
Premature Activation	263	263
Adverse Event Without Identified Device or Use Problem	248	248
Failure to Fire	231	231
Separation Failure	231	231
Premature Separation	174	174
Detachment of Device or Device Component	137	137
Use of Device Problem	127	127
Material Deformation	88	88
Human-Device Interface Problem	79	79
Positioning Failure	70	70
Material Twisted/Bent	70	70
Entrapment of Device	67	67
Difficult or Delayed Separation	60	60
Improper or Incorrect Procedure or Method	41	41
Device Fell	36	36
Difficult to Remove	36	36
Failure to Advance	30	30
Mechanical Problem	29	29
Activation Problem	26	26
Defective Device	24	24
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
Misfire	15	15
Migration	15	15
Material Fragmentation	14	14
Firing Problem	13	13
Peeled/Delaminated	13	13
Insufficient Information	11	11
Unraveled Material	9	9
Material Integrity Problem	8	8
Nonstandard Device	8	8
Activation Failure	8	8
Material Protrusion/Extrusion	8	8
Appropriate Term/Code Not Available	7	7
Failure to Deliver	7	7
Failure to Discharge	7	7
Unintended Movement	7	7
Failure to Form Staple	7	7
Failure to Disconnect	7	7
Defective Component	6	6
Device Reprocessing Problem	6	6
Separation Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2387	2387
No Consequences Or Impact To Patient	877	877
No Known Impact Or Consequence To Patient	249	249
Hemorrhage/Bleeding	162	162
Insufficient Information	78	78
Foreign Body In Patient	66	66
Gastrointestinal Hemorrhage	59	59
Perforation	40	40
No Code Available	18	18
Unspecified Tissue Injury	17	17
Device Embedded In Tissue or Plaque	16	16
Bowel Perforation	15	15
Tissue Damage	14	14
Blood Loss	12	12
No Patient Involvement	11	11
Laceration(s)	10	10
Abdominal Pain	8	8
Peritonitis	8	8
Injury	6	6
Failure of Implant	5	5
Hematoma	5	5
Pain	5	5
Pancreatitis	4	4
Unspecified Respiratory Problem	4	4
Ulcer	4	4
Hemostasis	4	4
Internal Organ Perforation	3	3
Hyperemia	3	3
Swelling/ Edema	3	3
Stenosis	3	3
Vomiting	3	3
Discomfort	3	3
Fever	3	3
Obstruction/Occlusion	3	3
Laceration(s) of Esophagus	3	3
Inflammation	3	3
Death	3	3
Abrasion	2	2
Chest Pain	2	2
Hematemesis	2	2
Aspiration/Inhalation	2	2
No Information	2	2
Nausea	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
Pneumonia	1	1
Abscess	1	1
Fluid Discharge	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