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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 2
ENDOCLOT PLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXTBIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 218 218
2020 73 73
2021 112 112
2022 135 135
2023 132 132
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 335 335
Failure to Fire 182 182
Obstruction of Flow 96 96
Complete Blockage 53 53
Adverse Event Without Identified Device or Use Problem 49 49
Device Handling Problem 41 41
Improper or Incorrect Procedure or Method 39 39
Entrapment of Device 27 27
Gas/Air Leak 21 21
Fracture 14 14
Use of Device Problem 10 10
Insufficient Flow or Under Infusion 9 9
Material Twisted/Bent 8 8
Crack 7 7
Explosion 7 7
Failure to Disconnect 5 5
Insufficient Information 4 4
Partial Blockage 4 4
Failure to Deliver 4 4
Off-Label Use 4 4
Infusion or Flow Problem 3 3
Patient Device Interaction Problem 3 3
Activation Problem 3 3
Defective Device 2 2
Difficult to Remove 2 2
Material Separation 2 2
Premature Activation 2 2
Inaccurate Delivery 2 2
Break 2 2
Material Fragmentation 1 1
Difficult to Insert 1 1
Inaccurate Flow Rate 1 1
Component Missing 1 1
Accessory Incompatible 1 1
Human-Device Interface Problem 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Mechanical Jam 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 301 301
No Consequences Or Impact To Patient 231 231
Gastrointestinal Hemorrhage 66 66
No Patient Involvement 37 37
No Known Impact Or Consequence To Patient 20 20
Hemorrhage/Bleeding 17 17
Device Embedded In Tissue or Plaque 14 14
Hemostasis 11 11
Insufficient Information 7 7
Perforation 4 4
Death 3 3
Exsanguination 3 3
Foreign Body Sensation in Eye 2 2
Unspecified Tissue Injury 2 2
Hypersensitivity/Allergic reaction 2 2
High Blood Pressure/ Hypertension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Irritation 1 1
Laceration(s) 1 1
Pain 1 1
Ulcer 1 1
Laceration(s) of Esophagus 1 1
Perforation of Esophagus 1 1
Obstruction/Occlusion 1 1
Chest Tightness/Pressure 1 1
Abdominal Distention 1 1
Pseudoaneurysm 1 1
Hematemesis 1 1
No Information 1 1
Ruptured Aneurysm 1 1
Embolism/Embolus 1 1
Respiratory Arrest 1 1
Eye Pain 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Local Reaction 1 1
Therapeutic Effects, Unexpected 1 1
Bowel Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wilson-Cook Medical Inc. II Jun-21-2023
2 Wilson-Cook Medical Inc. II Apr-17-2020
3 Wilson-Cook Medical Inc. II Sep-13-2019
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