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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
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 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 4
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OVESCO ENDOSCOPY AG
  SUBSTANTIALLY EQUIVALENT 2
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 2

MDR Year MDR Reports MDR Events
2018 393 393
2019 698 698
2020 504 504
2021 668 668
2022 522 522
2023 718 718

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 2031 2031
Difficult to Open or Close 393 393
Break 271 271
Separation Failure 218 218
Failure to Fire 203 203
Material Separation 198 198
Premature Activation 183 183
Premature Separation 129 129
Detachment of Device or Device Component 127 127
Use of Device Problem 117 117
Adverse Event Without Identified Device or Use Problem 113 113
Material Deformation 85 85
Human-Device Interface Problem 68 68
Positioning Failure 61 61
Entrapment of Device 59 59
Material Twisted/Bent 57 57
Difficult or Delayed Separation 55 55
Device Fell 37 37
Difficult to Remove 30 30
Failure to Advance 29 29
Mechanical Problem 26 26
Activation Problem 26 26
Defective Device 22 22
Improper or Incorrect Procedure or Method 19 19
Problem with Sterilization 18 18
Misfire 16 16
Physical Resistance/Sticking 16 16
Mechanical Jam 15 15
Difficult to Advance 15 15
Device Dislodged or Dislocated 15 15
Material Fragmentation 14 14
Firing Problem 13 13
Failure to Eject 12 12
Insufficient Information 11 11
Migration 11 11
Material Protrusion/Extrusion 11 11
Failure to Form Staple 8 8
Unraveled Material 8 8
Nonstandard Device 8 8
Failure to Deliver 7 7
Failure to Discharge 7 7
Appropriate Term/Code Not Available 7 7
Activation Failure 7 7
Unintended Movement 6 6
Separation Problem 6 6
Component Missing 6 6
Material Integrity Problem 6 6
Defective Component 5 5
Off-Label Use 5 5
Device Reprocessing Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Positioning Problem 4 4
Mechanics Altered 3 3
Failure to Disconnect 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Loss of or Failure to Bond 3 3
Contamination 3 3
Fracture 3 3
Product Quality Problem 3 3
Self-Activation or Keying 3 3
Unintended System Motion 3 3
Therapeutic or Diagnostic Output Failure 3 3
Packaging Problem 2 2
Ejection Problem 2 2
Failure to Clean Adequately 2 2
Unsealed Device Packaging 2 2
Device Slipped 2 2
Migration or Expulsion of Device 2 2
Detachment Of Device Component 2 2
Difficult or Delayed Positioning 2 2
Malposition of Device 2 2
Deformation Due to Compressive Stress 1 1
Capturing Problem 1 1
Device Operates Differently Than Expected 1 1
Difficult or Delayed Activation 1 1
Failure to Cut 1 1
Scratched Material 1 1
Output Problem 1 1
Inadequate User Interface 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Crack 1 1
Degraded 1 1
Failure To Adhere Or Bond 1 1
Component(s), broken 1 1
Loose or Intermittent Connection 1 1
Disconnection 1 1
Structural Problem 1 1
Particulates 1 1
Sharp Edges 1 1
Non Reproducible Results 1 1
Material Split, Cut or Torn 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1630 1630
No Consequences Or Impact To Patient 1207 1207
No Known Impact Or Consequence To Patient 282 282
Hemorrhage/Bleeding 133 133
Foreign Body In Patient 72 72
Insufficient Information 67 67
Gastrointestinal Hemorrhage 51 51
Perforation 33 33
Tissue Damage 21 21
No Code Available 19 19
No Patient Involvement 17 17
Device Embedded In Tissue or Plaque 16 16
Blood Loss 14 14
Unspecified Tissue Injury 13 13
Bowel Perforation 10 10
Laceration(s) 9 9
Injury 7 7
Peritonitis 5 5
Failure of Implant 5 5
Hemostasis 5 5
No Information 5 5
Unspecified Respiratory Problem 4 4
Abdominal Pain 4 4
Death 3 3
Hyperemia 3 3
Stenosis 3 3
Hematoma 3 3
Obstruction/Occlusion 3 3
Ulcer 3 3
Discomfort 3 3
Swelling/ Edema 3 3
Pancreatitis 3 3
Hematemesis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Laceration(s) of Esophagus 2 2
Pain 2 2
Inflammation 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Abscess 1 1
Adhesion(s) 1 1
Chest Pain 1 1
Fever 1 1
Fistula 1 1
Myocardial Infarction 1 1
Internal Organ Perforation 1 1
Hypersensitivity/Allergic reaction 1 1
Pneumonia 1 1
Therapeutic Response, Decreased 1 1
Perforation of Esophagus 1 1
Needle Stick/Puncture 1 1
Vomiting 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 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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