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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 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
AVANOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AVANOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES
  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
CREATIVE BALLOONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK INC.
  SUBSTANTIALLY EQUIVALENT 1
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
GRAVITAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 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
2019 1837 1837
2020 1641 1641
2021 1652 1652
2022 1650 1650
2023 1867 1867
2024 401 418

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4971 4988
Fluid/Blood Leak 611 611
Detachment of Device or Device Component 549 549
Break 486 486
Obstruction of Flow 253 253
Difficult to Remove 231 231
Malposition of Device 213 213
Material Rupture 183 183
Leak/Splash 175 175
Device Dislodged or Dislocated 151 151
Material Twisted/Bent 138 138
Material Split, Cut or Torn 133 133
Material Puncture/Hole 102 102
Unintended Deflation 101 101
Migration 85 85
Fracture 79 79
Crack 76 76
Deflation Problem 76 76
Material Separation 75 75
Patient Device Interaction Problem 66 66
Disconnection 64 64
Complete Blockage 56 56
Material Integrity Problem 55 55
Insufficient Information 54 54
No Apparent Adverse Event 49 49
Burst Container or Vessel 48 48
Inflation Problem 42 42
Migration or Expulsion of Device 42 42
Material Fragmentation 37 37
Use of Device Problem 37 37
Component Missing 35 35
Improper or Incorrect Procedure or Method 31 31
Physical Resistance/Sticking 31 31
Device Handling Problem 29 29
Difficult to Advance 28 28
Biocompatibility 27 27
Defective Device 27 27
Defective Component 23 23
Appropriate Term/Code Not Available 23 23
Entrapment of Device 22 22
Decrease in Pressure 19 19
Pressure Problem 19 19
Stretched 19 19
Fitting Problem 18 18
Material Perforation 18 18
Device Contamination with Chemical or Other Material 18 18
Product Quality Problem 18 18
Material Deformation 17 17
Separation Failure 15 15
Patient-Device Incompatibility 15 15
Loose or Intermittent Connection 15 15
Nonstandard Device 14 14
Degraded 14 14
Positioning Problem 14 14
Device Markings/Labelling Problem 14 14
Therapeutic or Diagnostic Output Failure 13 13
Misconnection 13 13
Material Too Rigid or Stiff 13 13
Device Fell 13 13
Partial Blockage 11 11
Positioning Failure 10 10
Off-Label Use 9 9
Inability to Irrigate 9 9
Unintended Movement 9 9
Deformation Due to Compressive Stress 9 9
Air/Gas in Device 9 9
Difficult or Delayed Separation 9 9
Suction Problem 8 8
Difficult to Open or Close 8 8
Device Contaminated During Manufacture or Shipping 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Collapse 8 8
Difficult to Flush 7 7
Expulsion 7 7
Gas/Air Leak 7 7
Device Displays Incorrect Message 7 7
Separation Problem 7 7
Failure to Advance 6 6
Contamination /Decontamination Problem 6 6
Volume Accuracy Problem 6 6
Flushing Problem 6 6
Display or Visual Feedback Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Device Slipped 5 5
No Display/Image 5 5
Material Frayed 5 5
Difficult to Insert 5 5
Unexpected Therapeutic Results 5 5
Inadequate or Insufficient Training 5 5
Connection Problem 5 5
Human-Device Interface Problem 5 5
No Flow 4 4
Output Problem 4 4
Structural Problem 4 4
Contamination 4 4
Material Disintegration 4 4
Inadequacy of Device Shape and/or Size 4 4
Missing Information 4 4
Unclear Information 3 3
Sharp Edges 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Infection 1617 1626
No Clinical Signs, Symptoms or Conditions 1521 1521
Unspecified Infection 1024 1024
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 869 871
No Consequences Or Impact To Patient 677 677
No Code Available 571 571
No Known Impact Or Consequence To Patient 409 409
Foreign Body In Patient 338 338
Insufficient Information 321 321
Post Operative Wound Infection 228 228
Ulcer 226 226
Peritonitis 173 173
Bowel Perforation 163 163
Pneumothorax 155 155
Hemorrhage/Bleeding 115 115
Pneumonia 112 112
Death 100 100
Stomach Ulceration 96 96
Perforation 91 91
Abscess 87 87
Pain 75 75
No Patient Involvement 73 73
Sepsis 62 62
Aspiration/Inhalation 61 61
Tissue Breakdown 60 60
Aspiration Pneumonitis 60 60
Pressure Sores 48 48
Gastrointestinal Hemorrhage 47 47
Discomfort 46 46
Obstruction/Occlusion 46 46
Abdominal Pain 44 44
Vomiting 41 41
Inflammation 39 39
Skin Inflammation/ Irritation 38 38
Laceration(s) 36 36
No Information 31 31
Device Embedded In Tissue or Plaque 30 30
Failure of Implant 28 28
Necrosis 26 26
Fluid Discharge 25 25
Granuloma 23 23
Fistula 22 22
Internal Organ Perforation 21 21
Needle Stick/Puncture 20 20
Skin Tears 20 20
Bacterial Infection 19 19
Cellulitis 19 19
Ulceration 18 18
Perforation of Esophagus 17 17
Cardiac Arrest 17 17
Anemia 17 17
Low Oxygen Saturation 16 16
Blood Loss 16 16
Unspecified Tissue Injury 15 15
Abdominal Distention 13 13
Injury 13 13
Nausea 13 13
Erosion 13 13
Feeding Problem 13 13
Fever 13 13
Erythema 12 12
Tachycardia 12 12
Respiratory Failure 12 12
Patient Problem/Medical Problem 12 12
Skin Erosion 11 11
Gastritis 11 11
Hypoxia 10 10
Tissue Damage 10 10
Skin Irritation 9 9
Hypoglycemia 9 9
Low Blood Pressure/ Hypotension 9 9
Hematoma 9 9
Burn(s) 8 8
Laceration(s) of Esophagus 8 8
Fungal Infection 8 8
Swelling/ Edema 8 8
Cough 7 7
Respiratory Distress 7 7
Pleural Effusion 7 7
Diarrhea 7 7
Dyspnea 6 6
Septic Shock 6 6
Shock 5 5
Rash 5 5
Skin Inflammation 5 5
Pulmonary Embolism 5 5
Adult Respiratory Distress Syndrome 5 5
Unintended Extubation 5 5
Drug Resistant Bacterial Infection 4 4
Respiratory Arrest 4 4
Anxiety 4 4
Distress 3 3
Swelling 3 3
Respiratory Distress Syndrome of Newborns 3 3
Renal Failure 3 3
Airway Obstruction 3 3
Wound Dehiscence 3 3
Atrial Fibrillation 3 3
Cardiopulmonary Arrest 3 3
Purulent Discharge 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. I Mar-01-2024
2 Avanos Medical, Inc. I May-13-2022
3 Avanos Medical, Inc. II Feb-07-2022
4 Avanos Medical, Inc. II Dec-07-2020
5 Avanos Medical, Inc. II Sep-17-2020
6 Avanos Medical, Inc. II Nov-14-2019
7 Boston Scientific Corporation II Apr-11-2024
8 C.R. Bard Inc II Jan-25-2024
9 Hollister Incorporated II Mar-26-2021
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