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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
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 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 3
MIRCO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OVESCO ENDOSCOPY AG
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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

MDR Year MDR Reports MDR Events
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 1890 1890
Difficult to Open or Close 442 442
Break 257 257
Material Separation 225 225
Separation Failure 222 222
Failure to Fire 220 220
Premature Activation 211 211
Adverse Event Without Identified Device or Use Problem 203 203
Premature Separation 145 145
Detachment of Device or Device Component 131 131
Use of Device Problem 116 116
Material Deformation 85 85
Human-Device Interface Problem 74 74
Entrapment of Device 61 61
Positioning Failure 60 60
Material Twisted/Bent 60 60
Difficult or Delayed Separation 59 59
Device Fell 36 36
Difficult to Remove 31 31
Mechanical Problem 27 27
Failure to Advance 26 26
Activation Problem 26 26
Defective Device 22 22
Improper or Incorrect Procedure or Method 21 21
Mechanical Jam 19 19
Problem with Sterilization 18 18
Difficult to Advance 16 16
Device Dislodged or Dislocated 16 16
Physical Resistance/Sticking 16 16
Failure to Eject 15 15
Misfire 15 15
Migration 14 14
Firing Problem 13 13
Material Fragmentation 13 13
Insufficient Information 11 11
Unraveled Material 9 9
Nonstandard Device 8 8
Material Protrusion/Extrusion 8 8
Material Integrity Problem 7 7
Failure to Disconnect 7 7
Failure to Form Staple 7 7
Failure to Discharge 7 7
Failure to Deliver 7 7
Appropriate Term/Code Not Available 7 7
Activation Failure 7 7
Separation Problem 6 6
Unintended Movement 6 6
Peeled/Delaminated 5 5
Defective Component 5 5
Off-Label Use 5 5
Device Reprocessing Problem 5 5
Component Missing 4 4
Product Quality Problem 3 3
Self-Activation or Keying 3 3
Contamination 3 3
Loss of or Failure to Bond 3 3
Difficult or Delayed Positioning 3 3
Unintended System Motion 3 3
Connection Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Mechanics Altered 3 3
Device Contamination with Chemical or Other Material 3 3
Packaging Problem 2 2
Positioning Problem 2 2
Difficult or Delayed Activation 2 2
Migration or Expulsion of Device 2 2
Fracture 2 2
Device Slipped 2 2
Unsealed Device Packaging 2 2
Failure to Clean Adequately 2 2
Ejection Problem 2 2
Noise, Audible 1 1
Sharp Edges 1 1
Non Reproducible Results 1 1
Particulates 1 1
Structural Problem 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1
Disconnection 1 1
Crack 1 1
Degraded 1 1
Component(s), broken 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Capturing Problem 1 1
Component or Accessory Incompatibility 1 1
Expulsion 1 1
Scratched Material 1 1
Output Problem 1 1
Inadequate User Interface 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 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 877 877
No Known Impact Or Consequence To Patient 249 249
Hemorrhage/Bleeding 142 142
Insufficient Information 70 70
Foreign Body In Patient 66 66
Gastrointestinal Hemorrhage 58 58
Perforation 37 37
No Code Available 18 18
Device Embedded In Tissue or Plaque 16 16
Tissue Damage 14 14
Unspecified Tissue Injury 13 13
Blood Loss 12 12
No Patient Involvement 11 11
Bowel Perforation 10 10
Laceration(s) 9 9
Abdominal Pain 7 7
Injury 6 6
Peritonitis 5 5
Failure of Implant 5 5
Hematoma 5 5
Hemostasis 4 4
Ulcer 4 4
Unspecified Respiratory Problem 4 4
Pancreatitis 3 3
Vomiting 3 3
Obstruction/Occlusion 3 3
Swelling/ Edema 3 3
Discomfort 3 3
Laceration(s) of Esophagus 3 3
Stenosis 3 3
Pain 3 3
Hyperemia 3 3
Inflammation 3 3
Death 3 3
Fever 2 2
Aspiration/Inhalation 2 2
Chest Pain 2 2
Abrasion 2 2
Internal Organ Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematemesis 2 2
No Information 2 2
Melena 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Needle Stick/Puncture 1 1
Fluid Discharge 1 1
Myocardial Infarction 1 1
Nausea 1 1
Urinary Tract Infection 1 1
Pneumonia 1 1
Septic Shock 1 1
Therapeutic Response, Decreased 1 1
Perforation of Esophagus 1 1
Abscess 1 1
Adhesion(s) 1 1
Fistula 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 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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