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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hemostatic device for endoscopic gastrointestinal use
Definition Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
Product CodeQAU
Regulation Number 878.4456
Device Class 2


Premarket Reviews
ManufacturerDecision
3-D MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCLOT PLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXTBIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 56 56
2019 218 218
2020 73 73
2021 112 112
2022 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 208 208
Activation Failure 207 207
Obstruction of Flow 83 83
Complete Blockage 51 51
Adverse Event Without Identified Device or Use Problem 44 44
Improper or Incorrect Procedure or Method 38 38
Device Handling Problem 24 24
Gas Leak 22 22
Use of Device Problem 17 17
Positioning Failure 16 16
Entrapment of Device 13 13
Fracture 10 10
Insufficient Flow or Under Infusion 9 9
Crack 7 7
Explosion 7 7
Patient Device Interaction Problem 4 4
Material Twisted/Bent 4 4
Partial Blockage 4 4
Failure to Deliver 4 4
Off-Label Use 3 3
Device Operates Differently Than Expected 3 3
Insufficient Information 3 3
Activation Problem 3 3
Human-Device Interface Problem 2 2
Difficult to Remove 2 2
Material Separation 2 2
Inaccurate Delivery 2 2
Failure to Disconnect 2 2
Defective Device 2 2
Break 2 2
Material Fragmentation 1 1
Premature Activation 1 1
Inaccurate Flow Rate 1 1
Component Missing 1 1
Infusion or Flow Problem 1 1
Mechanical Jam 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or SeparationProblem 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 279 279
No Clinical Signs, Symptoms or Conditions 159 159
Gastrointestinal Hemorrhage 47 47
No Patient Involvement 42 42
No Known Impact Or Consequence To Patient 22 22
Hemorrhage/Bleeding 17 17
Hemostasis 11 11
Perforation 5 5
Insufficient Information 5 5
Device Embedded In Tissue or Plaque 3 3
Death 3 3
Exsanguination 3 3
Hypersensitivity/Allergic reaction 2 2
Therapeutic Effects, Unexpected 2 2
Hematemesis 1 1
Unspecified Tissue Injury 1 1
No Information 1 1
Ruptured Aneurysm 1 1
Embolism/Embolus 1 1
Respiratory Arrest 1 1
Local Reaction 1 1
Bowel Perforation 1 1
Unspecified Infection 1 1
Inflammation 1 1
Irritation 1 1
Laceration(s) 1 1
Pain 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Ulcer 1 1
Perforation of Esophagus 1 1
Chest Tightness/Pressure 1 1
Abdominal Distention 1 1
Pseudoaneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wilson-Cook Medical Inc. II Apr-17-2020
2 Wilson-Cook Medical Inc. II Sep-13-2019
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