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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
Regulation Description Hemostatic device for intraluminal 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
ENDOCLOT PLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 56 56
2019 218 218
2020 73 73
2021 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 206 206
Activation Failure 72 72
Obstruction of Flow 58 58
Complete Blockage 38 38
Improper or Incorrect Procedure or Method 30 30
Gas Leak 22 22
Use of Device Problem 17 17
Positioning Failure 16 16
Device Handling Problem 9 9
Fracture 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Explosion 7 7
Crack 7 7
Entrapment of Device 5 5
Partial Blockage 4 4
Failure to Deliver 4 4
Patient Device Interaction Problem 4 4
Activation Problem 3 3
Device Operates Differently Than Expected 3 3
Insufficient Flow or Under Infusion 3 3
Inaccurate Delivery 2 2
Difficult to Remove 2 2
Material Separation 2 2
Human-Device Interface Problem 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
Appropriate Term/Code Not Available 1 1
Material Fragmentation 1 1
Premature Activation 1 1
Off-Label Use 1 1
Break 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or SeparationProblem 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 Patient Involvement 42 42
No Known Impact Or Consequence To Patient 22 22
No Clinical Signs, Symptoms or Conditions 18 18
Hemostasis 11 11
Death 3 3
Hemorrhage/Bleeding 3 3
Exsanguination 2 2
Perforation 2 2
Therapeutic Effects, Unexpected 2 2
Inflammation 1 1
Irritation 1 1
Ulcer 1 1
Bowel Perforation 1 1
No Information 1 1
Gastrointestinal Hemorrhage 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Pain 1 1
Chest Tightness/Pressure 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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