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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 2
BOEHRINGER LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES LLC
  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
DEGANIA SILICONE LTD.
  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 4
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 688 893

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5009 5214
Fluid/Blood Leak 621 621
Detachment of Device or Device Component 566 566
Break 506 506
Obstruction of Flow 272 272
Difficult to Remove 238 238
Malposition of Device 237 237
Material Rupture 201 201
Leak/Splash 188 188
Device Dislodged or Dislocated 156 156
Material Split, Cut or Torn 143 143
Material Twisted/Bent 140 140
Material Puncture/Hole 116 116
Unintended Deflation 113 113
Fracture 87 87
Migration 85 85
Material Separation 83 83
Crack 80 80
Deflation Problem 77 77
Disconnection 73 73
Patient Device Interaction Problem 73 73
Complete Blockage 58 58
Insufficient Information 56 56
Material Integrity Problem 55 55
Burst Container or Vessel 53 53
No Apparent Adverse Event 50 50
Inflation Problem 47 47
Material Fragmentation 42 42
Migration or Expulsion of Device 42 42
Use of Device Problem 42 42
Component Missing 37 37
Improper or Incorrect Procedure or Method 31 31
Physical Resistance/Sticking 31 31
Device Handling Problem 29 29
Defective Device 28 28
Difficult to Advance 28 28
Biocompatibility 27 27
Stretched 24 24
Defective Component 23 23
Appropriate Term/Code Not Available 23 23
Entrapment of Device 22 22
Pressure Problem 20 20
Product Quality Problem 19 19
Decrease in Pressure 19 19
Material Deformation 18 18
Device Contamination with Chemical or Other Material 18 18
Fitting Problem 18 18
Material Perforation 18 18
Separation Failure 18 18
Patient-Device Incompatibility 15 15
Nonstandard Device 15 15
Loose or Intermittent Connection 15 15
Misconnection 14 14
Material Too Rigid or Stiff 14 14
Degraded 14 14
Device Markings/Labelling Problem 14 14
Positioning Problem 14 14
Therapeutic or Diagnostic Output Failure 13 13
Device Fell 13 13
Difficult or Delayed Separation 12 12
Unintended Movement 12 12
Partial Blockage 11 11
Positioning Failure 10 10
Restricted Flow rate 10 10
Off-Label Use 10 10
Deformation Due to Compressive Stress 10 10
Difficult to Open or Close 9 9
Inability to Irrigate 9 9
Air/Gas in Device 9 9
Separation Problem 8 8
Collapse 8 8
Device Contaminated During Manufacture or Shipping 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Suction Problem 8 8
Device Displays Incorrect Message 7 7
Gas/Air Leak 7 7
Expulsion 7 7
Difficult to Flush 7 7
Flushing Problem 6 6
Difficult to Fold, Unfold or Collapse 6 6
Display or Visual Feedback Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Contamination /Decontamination Problem 6 6
Failure to Advance 6 6
Volume Accuracy Problem 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Slipped 5 5
Unexpected Therapeutic Results 5 5
Inadequate or Insufficient Training 5 5
Human-Device Interface Problem 5 5
Connection Problem 5 5
No Display/Image 5 5
Difficult to Insert 5 5
Material Frayed 5 5
Contamination 4 4
Material Disintegration 4 4
Output Problem 4 4
Structural Problem 4 4
Missing Information 4 4
No Flow 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1681 1681
Skin Infection 1639 1759
Unspecified Infection 1025 1025
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 900 943
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 369 369
Insufficient Information 348 348
Ulcer 232 232
Post Operative Wound Infection 228 228
Peritonitis 177 177
Bowel Perforation 169 169
Pneumothorax 167 167
Hemorrhage/Bleeding 120 120
Pneumonia 114 114
Stomach Ulceration 101 101
Death 100 100
Perforation 93 93
Abscess 91 91
Pain 82 82
No Patient Involvement 73 73
Aspiration Pneumonitis 64 64
Sepsis 64 64
Aspiration/Inhalation 63 63
Tissue Breakdown 61 61
Gastrointestinal Hemorrhage 51 52
Discomfort 49 49
Pressure Sores 49 49
Obstruction/Occlusion 47 47
Abdominal Pain 45 45
Vomiting 44 44
Skin Inflammation/ Irritation 40 40
Inflammation 39 39
Laceration(s) 36 36
No Information 31 31
Device Embedded In Tissue or Plaque 30 30
Failure of Implant 28 28
Necrosis 27 27
Fluid Discharge 25 25
Granuloma 24 24
Fistula 22 22
Bacterial Infection 22 22
Internal Organ Perforation 22 22
Skin Tears 21 21
Cellulitis 21 21
Needle Stick/Puncture 20 20
Low Oxygen Saturation 19 19
Feeding Problem 19 19
Cardiac Arrest 18 18
Ulceration 18 18
Perforation of Esophagus 17 17
Anemia 17 17
Unspecified Tissue Injury 17 17
Blood Loss 16 16
Abdominal Distention 14 14
Fever 14 14
Erythema 14 14
Erosion 13 13
Injury 13 13
Nausea 13 13
Tachycardia 12 12
Respiratory Failure 12 12
Patient Problem/Medical Problem 12 12
Cough 11 11
Fungal Infection 11 11
Laceration(s) of Esophagus 11 11
Skin Erosion 11 11
Gastritis 11 11
Hematoma 11 11
Hypoxia 10 10
Tissue Damage 10 10
Skin Irritation 9 9
Hypoglycemia 9 9
Low Blood Pressure/ Hypotension 9 9
Burn(s) 9 9
Pleural Effusion 8 8
Swelling/ Edema 8 8
Drug Resistant Bacterial Infection 7 7
Respiratory Distress 7 7
Diarrhea 7 7
Dyspnea 6 6
Septic Shock 6 6
Unintended Extubation 6 6
Unspecified Respiratory Problem 5 5
Shock 5 5
Rash 5 5
Anxiety 5 5
Skin Inflammation 5 5
Pulmonary Embolism 5 5
Adult Respiratory Distress Syndrome 5 5
Airway Obstruction 4 4
Renal Failure 4 4
Respiratory Arrest 4 4
Respiratory Insufficiency 4 4
Unspecified Gastrointestinal Problem 4 4
Hematemesis 3 3
Constipation 3 3
Ascites 3 3
Distress 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Technology Inc II Jun-28-2024
2 Avanos Medical, Inc. I Mar-01-2024
3 Avanos Medical, Inc. I May-13-2022
4 Avanos Medical, Inc. II Feb-07-2022
5 Avanos Medical, Inc. II Dec-07-2020
6 Avanos Medical, Inc. II Sep-17-2020
7 Avanos Medical, Inc. II Nov-14-2019
8 Boston Scientific Corporation II Apr-11-2024
9 C.R. Bard Inc II Jan-25-2024
10 Hollister Incorporated II Mar-26-2021
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