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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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OVESCO ENDOSCOPY AG
  SUBSTANTIALLY EQUIVALENT 6
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 234 234

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 2571 2571
Difficult to Open or Close 451 451
Premature Activation 305 305
Break 290 290
Separation Failure 267 267
Material Separation 227 227
Failure to Fire 220 220
Adverse Event Without Identified Device or Use Problem 217 217
Premature Separation 145 145
Detachment of Device or Device Component 137 137
Use of Device Problem 124 124
Material Deformation 102 102
Positioning Failure 80 80
Human-Device Interface Problem 76 76
Entrapment of Device 63 63
Material Twisted/Bent 60 60
Difficult or Delayed Separation 59 59
Failure to Advance 52 52
Device Fell 37 37
Difficult to Remove 33 33
Mechanical Problem 27 27
Activation Problem 26 26
Improper or Incorrect Procedure or Method 24 24
Defective Device 24 24
Mechanical Jam 21 21
Problem with Sterilization 18 18
Device Dislodged or Dislocated 17 17
Misfire 16 16
Difficult to Advance 16 16
Physical Resistance/Sticking 16 16
Failure to Eject 15 15
Migration 14 14
Material Fragmentation 14 14
Detachment Of Device Component 13 13
Firing Problem 13 13
Material Protrusion/Extrusion 12 12
Fracture 12 12
Failure to Form Staple 11 11
Insufficient Information 11 11
Unraveled Material 9 9
Failure to Disconnect 8 8
Nonstandard Device 8 8
Failure to Discharge 7 7
Component Missing 7 7
Failure to Deliver 7 7
Appropriate Term/Code Not Available 7 7
Activation Failure 7 7
Material Integrity Problem 7 7
Unintended Movement 6 6
Separation Problem 6 6
Device Operates Differently Than Expected 6 6
Migration or Expulsion of Device 6 6
Off-Label Use 6 6
Peeled/Delaminated 6 6
Device Reprocessing Problem 5 5
Defective Component 5 5
Device Contamination with Chemical or Other Material 5 5
Mechanics Altered 4 4
Positioning Problem 4 4
Contamination /Decontamination Problem 4 4
Failure To Adhere Or Bond 4 4
Difficult or Delayed Positioning 4 4
Loss of or Failure to Bond 3 3
Contamination 3 3
Self-Activation or Keying 3 3
Product Quality Problem 3 3
Unintended System Motion 3 3
Connection Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Ejection Problem 2 2
Failure to Clean Adequately 2 2
Packaging Problem 2 2
Difficult or Delayed Activation 2 2
Malposition of Device 2 2
Unsealed Device Packaging 2 2
Sticking 2 2
Device Slipped 2 2
Component Falling 2 2
Bent 2 2
Loose or Intermittent Connection 2 2
Disconnection 1 1
Component(s), broken 1 1
Crack 1 1
Degraded 1 1
Retraction Problem 1 1
Particulates 1 1
No Device Output 1 1
Deformation Due to Compressive Stress 1 1
Capturing Problem 1 1
Failure to Cut 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Expulsion 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
Component or Accessory Incompatibility 1 1
Device Or Device Fragments Location Unknown 1 1
Device Packaging Compromised 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1964 1964
No Consequences Or Impact To Patient 1678 1678
No Known Impact Or Consequence To Patient 338 338
Hemorrhage/Bleeding 156 156
Foreign Body In Patient 135 135
Insufficient Information 70 70
Gastrointestinal Hemorrhage 58 58
Perforation 42 42
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
Hemostasis 14 14
Unspecified Tissue Injury 13 13
Bowel Perforation 10 10
Laceration(s) 10 10
Injury 8 8
Abdominal Pain 7 7
No Information 6 6
Ulcer 5 5
Hematoma 5 5
Failure of Implant 5 5
Inflammation 5 5
Peritonitis 5 5
Death 4 4
Discomfort 4 4
Laceration(s) of Esophagus 4 4
Unspecified Respiratory Problem 4 4
Obstruction/Occlusion 3 3
Swelling/ Edema 3 3
Pancreatitis 3 3
Hyperemia 3 3
Stenosis 3 3
Pain 3 3
Vomiting 3 3
Internal Organ Perforation 2 2
Chest Pain 2 2
Fever 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Abscess 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematemesis 2 2
Melena 1 1
Patient Problem/Medical Problem 1 1
Needle Stick/Puncture 1 1
Fluid Discharge 1 1
Perforation of Esophagus 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Adhesion(s) 1 1
Cardiopulmonary Arrest 1 1
Fistula 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Pneumonia 1 1
Septic Shock 1 1
Myocardial Infarction 1 1
Nausea 1 1
Occlusion 1 1
Urinary Tract Infection 1 1
Therapeutic Response, Decreased 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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