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U.S. Department of Health and Human Services

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 CodePKL
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO ENDOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
APONOS MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING ZKSK TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU AGS MEDTECH 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
MICRO-TECH (NANJING) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
MICRO-TECH (NANJING) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRCO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OVESCO ENDOSCOPY AG
  SUBSTANTIALLY EQUIVALENT 7
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 34 34
2016 128 128
2017 398 398
2018 393 393
2019 698 698
2020 504 504
2021 668 668
2022 522 522
2023 863 863
2024 705 705

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 2805 2805
Difficult to Open or Close 540 540
Premature Activation 357 357
Break 304 304
Material Separation 292 292
Separation Failure 276 276
Adverse Event Without Identified Device or Use Problem 263 263
Failure to Fire 231 231
Premature Separation 174 174
Detachment of Device or Device Component 143 143
Use of Device Problem 135 135
Material Deformation 105 105
Positioning Failure 90 90
Human-Device Interface Problem 81 81
Material Twisted/Bent 70 70
Entrapment of Device 69 69
Difficult or Delayed Separation 60 60
Failure to Advance 56 56
Improper or Incorrect Procedure or Method 44 44
Difficult to Remove 38 38
Device Fell 37 37
Mechanical Problem 29 29
Activation Problem 26 26
Defective Device 26 26
Device Dislodged or Dislocated 25 25
Mechanical Jam 22 22
Problem with Sterilization 18 18
Difficult to Advance 17 17
Failure to Eject 16 16
Physical Resistance/Sticking 16 16
Misfire 16 16
Material Fragmentation 15 15
Migration 15 15
Peeled/Delaminated 14 14
Firing Problem 13 13
Detachment Of Device Component 13 13
Material Protrusion/Extrusion 12 12
Fracture 12 12
Insufficient Information 11 11
Failure to Form Staple 11 11
Unraveled Material 9 9
Material Integrity Problem 8 8
Activation Failure 8 8
Failure to Disconnect 8 8
Nonstandard Device 8 8
Unintended Movement 7 7
Failure to Discharge 7 7
Component Missing 7 7
Failure to Deliver 7 7
Appropriate Term/Code Not Available 7 7

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 1678 1678
No Known Impact Or Consequence To Patient 338 338
Hemorrhage/Bleeding 176 176
Foreign Body In Patient 135 135
Insufficient Information 78 78
Gastrointestinal Hemorrhage 59 59
Perforation 45 45
Tissue Damage 38 38
No Code Available 22 22
No Patient Involvement 19 19
Device Embedded In Tissue or Plaque 18 18
Blood Loss 18 18
Unspecified Tissue Injury 17 17
Bowel Perforation 15 15
Hemostasis 14 14
Laceration(s) 11 11
Abdominal Pain 8 8
Injury 8 8
Peritonitis 8 8
No Information 6 6
Ulcer 5 5
Pain 5 5
Inflammation 5 5
Hematoma 5 5
Failure of Implant 5 5
Laceration(s) of Esophagus 4 4
Unspecified Respiratory Problem 4 4
Death 4 4
Pancreatitis 4 4
Discomfort 4 4
Internal Organ Perforation 3 3
Obstruction/Occlusion 3 3
Hyperemia 3 3
Fever 3 3
Swelling/ Edema 3 3
Vomiting 3 3
Stenosis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abscess 2 2
Hematemesis 2 2
Nausea 2 2
Chest Pain 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Hypersensitivity/Allergic reaction 1 1
Septic Shock 1 1
Cardiopulmonary Arrest 1 1
Occlusion 1 1
Pneumonia 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
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