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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubes, gastrointestinal (and accessories)
Product CodeKNT
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 2
ASPIRE BARIATRICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ASPIRE BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONIX DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CREATIVE BALLOONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK INC.
  SUBSTANTIALLY EQUIVALENT 1
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
GRAVITAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NASER DIB GABINET LEKARKSI NASMED
  SUBSTANTIALLY EQUIVALENT 1
NASOGASTRIC FEEDING SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROSYS INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESHAPE LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 3
STANDARD BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOOLS FOR SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 2

MDR Year MDR Reports MDR Events
2018 1899 1899
2019 1837 1837
2020 1641 1641
2021 1652 1652
2022 1650 1650
2023 1340 1340

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5354 5354
Fluid/Blood Leak 719 719
Detachment of Device or Device Component 597 597
Break 574 574
Leak/Splash 339 339
Difficult to Remove 241 241
Malposition of Device 215 215
Device Dislodged or Dislocated 180 180
Material Rupture 174 174
Obstruction of Flow 169 169
Deflation Problem 157 157
Material Twisted/Bent 152 152
Material Split, Cut or Torn 118 118
Material Puncture/Hole 103 103
Disconnection 95 95
Migration 92 92
Crack 90 90
Fracture 80 80
Material Separation 76 76
Insufficient Information 71 71
Unintended Deflation 68 68
Burst Container or Vessel 66 66
Inflation Problem 65 65
Detachment Of Device Component 64 64
Complete Blockage 63 63
Material Integrity Problem 58 58
Migration or Expulsion of Device 57 57
Patient Device Interaction Problem 56 56
Use of Device Problem 46 46
No Apparent Adverse Event 39 39
Improper or Incorrect Procedure or Method 38 38
Component Missing 38 38
Patient-Device Incompatibility 37 37
Material Fragmentation 36 36
Appropriate Term/Code Not Available 36 36
Device Handling Problem 33 33
Device Contamination with Chemical or Other Material 33 33
Physical Resistance/Sticking 31 31
Kinked 30 30
Defective Component 30 30
Defective Device 27 27
Difficult to Advance 25 25
Biocompatibility 25 25
Material Perforation 25 25
Fitting Problem 23 23
Entrapment of Device 23 23
Material Deformation 22 22
Positioning Problem 20 20
Pressure Problem 19 19
Loose or Intermittent Connection 19 19
Partial Blockage 18 18
Product Quality Problem 17 17
Nonstandard Device 16 16
Occlusion Within Device 16 16
Decrease in Pressure 16 16
Separation Failure 15 15
Device Fell 15 15
Device Markings/Labelling Problem 14 14
Device Operates Differently Than Expected 14 14
Degraded 13 13
Therapeutic or Diagnostic Output Failure 13 13
Misconnection 12 12
Stretched 12 12
Hole In Material 11 11
Positioning Failure 11 11
Material Frayed 10 10
Material Too Rigid or Stiff 10 10
Difficult to Open or Close 10 10
Device Displays Incorrect Message 10 10
Deformation Due to Compressive Stress 10 10
Human-Device Interface Problem 10 10
Difficult or Delayed Separation 9 9
Difficult to Flush 9 9
Inability to Irrigate 9 9
No Display/Image 8 8
Off-Label Use 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Suction Problem 8 8
Gas/Air Leak 8 8
No Flow 8 8
Unintended Movement 7 7
Expulsion 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Air/Gas in Device 7 7
Separation Problem 7 7
Volume Accuracy Problem 7 7
Device Slipped 7 7
Display or Visual Feedback Problem 7 7
Contamination 6 6
Mechanical Problem 6 6
Flushing Problem 6 6
Collapse 6 6
Difficult to Insert 6 6
Inadequacy of Device Shape and/or Size 6 6
Unexpected Therapeutic Results 6 6
Contamination /Decontamination Problem 6 6
Connection Problem 6 6
Failure to Advance 6 6
Device Contaminated During Manufacture or Shipping 6 6
Torn Material 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1410 1410
Skin Infection 1320 1320
No Clinical Signs, Symptoms or Conditions 1248 1248
No Consequences Or Impact To Patient 1111 1111
No Code Available 789 789
No Known Impact Or Consequence To Patient 764 764
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 728 728
Post Operative Wound Infection 352 352
Foreign Body In Patient 300 300
Insufficient Information 291 291
Ulcer 270 270
Peritonitis 214 214
Pneumothorax 196 196
Bowel Perforation 165 165
No Patient Involvement 159 159
Hemorrhage/Bleeding 155 155
Death 151 151
Pneumonia 129 129
Perforation 110 110
Abscess 93 93
Pain 82 82
Aspiration/Inhalation 79 79
No Information 79 79
Stomach Ulceration 73 73
Sepsis 71 71
Pressure Sores 70 70
Tissue Breakdown 60 60
Obstruction/Occlusion 50 50
Discomfort 48 48
Aspiration Pneumonitis 47 47
Device Embedded In Tissue or Plaque 45 45
Abdominal Pain 45 45
Vomiting 43 43
Inflammation 40 40
Laceration(s) 38 38
Gastrointestinal Hemorrhage 37 37
Skin Inflammation/ Irritation 28 28
Blood Loss 27 27
Fistula 27 27
Internal Organ Perforation 27 28
Necrosis 26 26
Injury 26 26
Tissue Damage 23 23
Ulceration 23 23
Cellulitis 22 22
Fluid Discharge 22 22
Patient Problem/Medical Problem 21 21
Needle Stick/Puncture 21 21
Granuloma 21 21
Failure of Implant 21 21
Low Oxygen Saturation 20 20
Skin Tears 19 19
Cardiac Arrest 19 19
Anemia 18 18
Perforation of Esophagus 18 18
Bacterial Infection 17 17
Erosion 16 16
Nausea 15 15
Burn(s) 14 14
Fever 14 14
Erythema 14 14
Feeding Problem 13 13
Skin Irritation 13 13
Respiratory Failure 13 13
Abdominal Distention 13 13
Unspecified Tissue Injury 13 13
Respiratory Distress 12 12
Gastritis 12 12
Low Blood Pressure/ Hypotension 12 12
Skin Erosion 11 11
Laceration(s) of Esophagus 10 10
Tachycardia 10 10
Diarrhea 10 10
Dyspnea 9 9
Hematoma 9 9
Hypoglycemia 9 9
Hypoxia 9 9
Pleural Effusion 9 9
Pulmonary Embolism 8 8
Fungal Infection 7 7
Swelling/ Edema 7 7
Weight Changes 6 6
Skin Inflammation 5 5
Unintended Extubation 5 5
Cough 5 5
Rupture 5 5
Septic Shock 5 5
Shock 4 4
Skin Discoloration 4 4
Purulent Discharge 4 4
Exposure to Body Fluids 4 4
Adult Respiratory Distress Syndrome 4 4
Hypersensitivity/Allergic reaction 4 4
Headache 4 4
Hemothorax 3 3
Cardiopulmonary Arrest 3 3
Ischemia 3 3
Itching Sensation 3 3
Airway Obstruction 3 3
Adhesion(s) 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. I May-13-2022
2 Avanos Medical, Inc. II Feb-07-2022
3 Avanos Medical, Inc. II Dec-07-2020
4 Avanos Medical, Inc. II Sep-17-2020
5 Avanos Medical, Inc. II Nov-14-2019
6 COVIDIEN LLC II Dec-11-2018
7 Cook Inc. II Mar-01-2018
8 Covidien LLC II Feb-20-2018
9 Hollister Incorporated II Mar-26-2021
10 Neomed Inc III Nov-30-2018
11 Teleflex Medical Europe Ltd II Apr-12-2018
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