Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 324 324

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 2607 2607
Difficult to Open or Close 464 464
Premature Activation 325 325
Break 292 292
Separation Failure 270 270
Material Separation 235 235
Adverse Event Without Identified Device or Use Problem 231 231
Failure to Fire 222 222
Premature Separation 149 149
Detachment of Device or Device Component 137 137
Use of Device Problem 127 127
Material Deformation 103 103
Positioning Failure 83 83
Human-Device Interface Problem 77 77
Entrapment of Device 63 63
Material Twisted/Bent 62 62
Difficult or Delayed Separation 60 60
Failure to Advance 55 55
Device Fell 37 37
Difficult to Remove 36 36
Mechanical Problem 27 27
Improper or Incorrect Procedure or Method 27 27
Defective Device 26 26
Activation Problem 26 26
Mechanical Jam 21 21
Device Dislodged or Dislocated 21 21
Problem with Sterilization 18 18
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
Peeled/Delaminated 7 7
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
Off-Label Use 6 6
Migration or Expulsion of Device 6 6
Device Reprocessing Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Defective Component 5 5
Contamination /Decontamination Problem 4 4
Failure To Adhere Or Bond 4 4
Difficult or Delayed Positioning 4 4
Positioning Problem 4 4
Mechanics Altered 4 4
Therapeutic or Diagnostic Output Failure 3 3
Loss of or Failure to Bond 3 3
Contamination 3 3
Unintended System Motion 3 3
Product Quality Problem 3 3
Self-Activation or Keying 3 3
Connection Problem 3 3
Malposition of Device 2 2
Sticking 2 2
Difficult or Delayed Activation 2 2
Device Slipped 2 2
Unsealed Device Packaging 2 2
Component Falling 2 2
Bent 2 2
Loose or Intermittent Connection 2 2
Packaging Problem 2 2
Ejection Problem 2 2
Failure to Clean Adequately 2 2
Sharp Edges 1 1
Non Reproducible Results 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
Scratched Material 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
Disconnection 1 1
Component(s), broken 1 1
Crack 1 1
Degraded 1 1
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
No Device Output 1 1
Retraction Problem 1 1
Failure to Cut 1 1
Device Or Device Fragments Location Unknown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2044 2044
No Consequences Or Impact To Patient 1678 1678
No Known Impact Or Consequence To Patient 338 338
Hemorrhage/Bleeding 160 160
Foreign Body In Patient 135 135
Insufficient Information 71 71
Gastrointestinal Hemorrhage 58 58
Perforation 43 43
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 12 12
Laceration(s) 10 10
Injury 8 8
Abdominal Pain 7 7
Peritonitis 6 6
No Information 6 6
Ulcer 5 5
Pain 5 5
Inflammation 5 5
Hematoma 5 5
Failure of Implant 5 5
Death 4 4
Discomfort 4 4
Laceration(s) of Esophagus 4 4
Unspecified Respiratory Problem 4 4
Pancreatitis 4 4
Swelling/ Edema 3 3
Obstruction/Occlusion 3 3
Hyperemia 3 3
Vomiting 3 3
Stenosis 3 3
Internal Organ Perforation 2 2
Chest Pain 2 2
Fever 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Abscess 2 2
Hematemesis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Increased Intra-Peritoneal Volume (IIPV) 1 1
Melena 1 1
Patient Problem/Medical Problem 1 1
Needle Stick/Puncture 1 1
Fluid Discharge 1 1
Perforation of Esophagus 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
Therapeutic Response, Decreased 1 1
Urinary Tract Infection 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
-
-