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
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	4
COOK ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
FINEMEDIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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
JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) 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	1
OVESCO ENDOSCOPY AG
	SUBSTANTIALLY EQUIVALENT	2
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	2280	2280
Difficult to Open or Close	847	847
Material Separation	598	598
Adverse Event Without Identified Device or Use Problem	421	421
Failure to Fire	329	329
Premature Activation	315	315
Premature Separation	294	294
Separation Failure	271	271
Break	235	237
Use of Device Problem	221	221
Detachment of Device or Device Component	133	134
Improper or Incorrect Procedure or Method	101	101
Material Deformation	88	88
Human-Device Interface Problem	87	87
Entrapment of Device	82	82
Material Twisted/Bent	79	79
Positioning Failure	76	76
Difficult or Delayed Separation	63	63
Mechanical Problem	34	34
Difficult to Remove	32	32
Activation Failure	25	25
Defective Device	23	23
Physical Resistance/Sticking	21	21
Device Dislodged or Dislocated	20	20
Mechanical Jam	20	20
Failure to Advance	19	19
Activation Problem	18	19
Peeled/Delaminated	17	17
Failure to Eject	16	16
Problem with Sterilization	16	16
Insufficient Information	15	15
Migration	15	15
Misfire	15	15
Firing Problem	14	14
Difficult to Advance	13	13
Device Fell	13	13
Material Integrity Problem	11	11
Off-Label Use	9	9
Separation Problem	9	9
Unintended Movement	8	8
Unraveled Material	8	8
Nonstandard Device	8	8
Appropriate Term/Code Not Available	7	7
Failure to Disconnect	7	7
Device Reprocessing Problem	7	7
Positioning Problem	6	6
Failure to Form Staple	6	7
Device Contamination with Chemical or Other Material	5	5
Difficult or Delayed Positioning	5	5
Material Fragmentation	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3709	3709
No Consequences Or Impact To Patient	384	385
Hemorrhage/Bleeding	180	180
Bowel Perforation	99	99
Insufficient Information	99	101
No Known Impact Or Consequence To Patient	94	95
Gastrointestinal Hemorrhage	67	67
Foreign Body In Patient	59	59
Perforation	49	49
Unspecified Tissue Injury	41	41
Abdominal Pain	11	11
Laceration(s)	11	11
Blood Loss	9	9
Device Embedded In Tissue or Plaque	8	8
Internal Organ Perforation	8	8
Hypersensitivity/Allergic reaction	8	8
Peritonitis	8	8
No Code Available	6	6
Pain	6	6
Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pancreatitis	5	5
Failure of Implant	5	5
Ulcer	5	5
Unspecified Respiratory Problem	4	4
Tissue Damage	4	4
No Patient Involvement	4	4
Perforation of Esophagus	4	4
Obstruction/Occlusion	3	3
Fever	3	3
Inflammation	3	3
Hematoma	3	3
Vomiting	3	3
Discomfort	3	3
Stenosis	3	3
Swelling/ Edema	3	3
Unspecified Gastrointestinal Problem	3	3
Laceration(s) of Esophagus	2	2
Unspecified Infection	2	2
Chest Pain	2	2
Wound Dehiscence	2	2
No Information	2	2
Hematemesis	2	2
Death	2	2
Nausea	2	2
Urinary Tract Infection	1	1
Fistula	1	1
Low Blood Pressure/ Hypotension	1	1
Airway Obstruction	1	1
Melena	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Jun-21-2023