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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
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
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 108 108

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 1742 1742
Difficult to Open or Close 284 284
Break 234 234
Separation Failure 201 201
Failure to Fire 188 188
Material Separation 140 140
Premature Activation 115 115
Detachment of Device or Device Component 103 103
Premature Separation 102 102
Use of Device Problem 89 89
Material Deformation 78 78
Adverse Event Without Identified Device or Use Problem 65 65
Difficult or Delayed Separation 53 53
Entrapment of Device 49 49
Material Twisted/Bent 48 48
Human-Device Interface Problem 48 48
Device Fell 35 35
Positioning Failure 33 33
Difficult to Remove 24 24
Activation Problem 24 24
Failure to Advance 20 20
Defective Device 19 19
Problem with Sterilization 18 18
Mechanical Problem 18 18
Difficult to Advance 15 15
Material Fragmentation 14 14
Misfire 13 13
Firing Problem 12 12
Physical Resistance/Sticking 11 11
Migration 11 11
Insufficient Information 11 11
Mechanical Jam 10 10
Device Dislodged or Dislocated 10 10
Material Protrusion/Extrusion 10 10
Improper or Incorrect Procedure or Method 9 9
Nonstandard Device 8 8
Failure to Deliver 7 7
Appropriate Term/Code Not Available 7 7
Component Missing 6 6
Unintended Movement 6 6
Failure to Form Staple 5 5
Activation Failure 5 5
Material Integrity Problem 5 5
Defective Component 5 5
Failure to Discharge 5 5
Off-Label Use 4 4
Device Contamination with Chemical or Other Material 4 4
Separation Problem 4 4
Failure to Eject 3 3
Contamination /Decontamination Problem 3 3
Positioning Problem 3 3
Product Quality Problem 3 3
Unraveled Material 3 3
Failure to Disconnect 3 3
Fracture 3 3
Loss of or Failure to Bond 3 3
Contamination 3 3
Detachment Of Device Component 2 2
Difficult or Delayed Positioning 2 2
Migration or Expulsion of Device 2 2
Unintended System Motion 2 2
Self-Activation or Keying 2 2
Packaging Problem 2 2
Mechanics Altered 2 2
Malposition of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Non Reproducible Results 1 1
Deformation Due to Compressive Stress 1 1
Capturing Problem 1 1
Failure to Cut 1 1
Difficult or Delayed Activation 1 1
Device Operates Differently Than Expected 1 1
Inadequate User Interface 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Scratched Material 1 1
Noise, Audible 1 1
Device Slipped 1 1
Structural Problem 1 1
Loose or Intermittent Connection 1 1
Disconnection 1 1
Crack 1 1
Degraded 1 1
Failure To Adhere Or Bond 1 1
Device Reprocessing Problem 1 1
Component(s), broken 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1207 1207
No Clinical Signs, Symptoms or Conditions 1100 1100
No Known Impact Or Consequence To Patient 282 282
Hemorrhage/Bleeding 100 100
Foreign Body In Patient 60 60
Insufficient Information 57 57
Gastrointestinal Hemorrhage 33 33
Perforation 29 29
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 10 10
Bowel Perforation 9 9
Laceration(s) 8 8
Injury 7 7
Peritonitis 5 5
Hemostasis 5 5
No Information 5 5
Unspecified Respiratory Problem 4 4
Abdominal Pain 4 4
Failure of Implant 4 4
Death 3 3
Hyperemia 3 3
Stenosis 3 3
Obstruction/Occlusion 3 3
Pancreatitis 3 3
Swelling/ Edema 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Laceration(s) of Esophagus 2 2
Pain 2 2
Discomfort 2 2
Abrasion 2 2
Hematoma 2 2
Fistula 1 1
Myocardial Infarction 1 1
Pneumonia 1 1
Abscess 1 1
Adhesion(s) 1 1
Aspiration/Inhalation 1 1
Chest Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Vomiting 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Perforation of Esophagus 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Hematemesis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 US Endoscopy Group Inc II Mar-13-2019
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