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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, gastro-enterostomy
Product CodeKGC
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
COAPTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
COAPTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
FIDMI MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 84 84
2019 90 90
2020 118 118
2021 73 73
2022 51 51
2023 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Break 242 242
Fracture 33 33
Detachment of Device or Device Component 30 30
Fluid/Blood Leak 26 26
Adverse Event Without Identified Device or Use Problem 23 23
Leak/Splash 21 21
Migration 7 7
Material Deformation 7 7
Device Dislodged or Dislocated 5 5
Unintended Movement 5 5
Material Fragmentation 5 5
Detachment Of Device Component 5 5
Fitting Problem 5 5
Defective Component 4 4
Separation Failure 4 4
Material Rupture 4 4
Material Integrity Problem 4 4
Difficult to Open or Close 3 3
Material Separation 3 3
Disconnection 3 3
Entrapment of Device 3 3
Deformation Due to Compressive Stress 3 3
Migration or Expulsion of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Infuse 3 3
Obstruction of Flow 2 2
Mechanical Problem 2 2
Reflux within Device 2 2
Difficult to Remove 2 2
Malposition of Device 2 2
Device Slipped 2 2
Difficult to Insert 2 2
Difficult to Advance 2 2
Material Twisted/Bent 2 2
Appropriate Term/Code Not Available 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Premature Separation 2 2
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Gas/Air Leak 1 1
Device-Device Incompatibility 1 1
Loose or Intermittent Connection 1 1
Unexpected Therapeutic Results 1 1
Restricted Flow rate 1 1
Difficult to Flush 1 1
Material Disintegration 1 1
Complete Blockage 1 1
Patient-Device Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Defective Device 1 1
Component Missing 1 1
Failure to Advance 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 149 149
No Known Impact Or Consequence To Patient 92 92
No Clinical Signs, Symptoms or Conditions 62 62
Foreign Body In Patient 39 39
Insufficient Information 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Device Embedded In Tissue or Plaque 10 10
No Code Available 9 9
Unspecified Infection 9 9
Abdominal Pain 8 8
Peritonitis 8 8
Pain 8 8
Perforation 5 5
Bowel Perforation 5 5
Hemorrhage/Bleeding 4 4
Erythema 3 3
Erosion 3 3
Seizures 3 3
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
Abdominal Cramps 2 2
Rash 2 2
Granuloma 2 2
Inflammation 2 2
Purulent Discharge 2 2
Internal Organ Perforation 2 2
Necrosis 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Bradycardia 1 1
Infarction, Cerebral 1 1
Death 1 1
Flatus 1 1
Bacterial Infection 1 1
Local Reaction 1 1
Pocket Erosion 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Injury 1 1
Skin Inflammation 1 1
Abdominal Distention 1 1
Sleep Dysfunction 1 1
Sepsis 1 1
Perforation of Vessels 1 1
Unspecified Blood or Lymphatic problem 1 1
Gastrointestinal Hemorrhage 1 1
Melena 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1
Skin Inflammation/ Irritation 1 1
No Information 1 1

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