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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 605 741

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4995 5131
Fluid/Blood Leak 615 615
Detachment of Device or Device Component 558 558
Break 500 500
Obstruction of Flow 270 270
Difficult to Remove 235 235
Malposition of Device 231 231
Material Rupture 192 192
Leak/Splash 185 185
Device Dislodged or Dislocated 155 155
Material Twisted/Bent 139 139
Material Split, Cut or Torn 139 139
Material Puncture/Hole 110 110
Unintended Deflation 106 106
Fracture 86 86
Migration 85 85
Material Separation 83 83
Crack 78 78
Deflation Problem 77 77
Patient Device Interaction Problem 73 73
Disconnection 71 71
Complete Blockage 58 58
Insufficient Information 56 56
Material Integrity Problem 55 55
Burst Container or Vessel 52 52
No Apparent Adverse Event 50 50
Inflation Problem 44 44
Material Fragmentation 42 42
Migration or Expulsion of Device 42 42
Use of Device Problem 41 41
Component Missing 36 36
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
Defective Component 23 23
Appropriate Term/Code Not Available 23 23
Stretched 22 22
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
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
Unintended Movement 9 9
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 1641 1641
Skin Infection 1631 1708
Unspecified Infection 1024 1024
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 890 917
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 362 362
Insufficient Information 341 341
Ulcer 230 230
Post Operative Wound Infection 228 228
Peritonitis 175 175
Bowel Perforation 166 166
Pneumothorax 165 165
Hemorrhage/Bleeding 118 118
Pneumonia 113 113
Death 100 100
Stomach Ulceration 100 100
Perforation 92 92
Abscess 90 90
Pain 80 80
No Patient Involvement 73 73
Aspiration Pneumonitis 63 63
Sepsis 63 63
Aspiration/Inhalation 62 62
Tissue Breakdown 61 61
Gastrointestinal Hemorrhage 51 52
Pressure Sores 49 49
Discomfort 49 49
Obstruction/Occlusion 47 47
Abdominal Pain 45 45
Vomiting 42 42
Inflammation 39 39
Skin Inflammation/ Irritation 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 23 23
Fistula 22 22
Internal Organ Perforation 22 22
Bacterial Infection 22 22
Cellulitis 21 21
Skin Tears 21 21
Needle Stick/Puncture 20 20
Low Oxygen Saturation 18 18
Ulceration 18 18
Cardiac Arrest 18 18
Anemia 17 17
Perforation of Esophagus 17 17
Feeding Problem 16 16
Blood Loss 16 16
Unspecified Tissue Injury 16 16
Abdominal Distention 13 13
Fever 13 13
Erythema 13 13
Erosion 13 13
Injury 13 13
Nausea 13 13
Tachycardia 12 12
Respiratory Failure 12 12
Patient Problem/Medical Problem 12 12
Laceration(s) of Esophagus 11 11
Fungal Infection 11 11
Skin Erosion 11 11
Gastritis 11 11
Hypoxia 10 10
Tissue Damage 10 10
Cough 10 10
Skin Irritation 9 9
Hypoglycemia 9 9
Low Blood Pressure/ Hypotension 9 9
Hematoma 9 9
Burn(s) 8 8
Swelling/ Edema 8 8
Diarrhea 7 7
Respiratory Distress 7 7
Pleural Effusion 7 7
Septic Shock 6 6
Dyspnea 6 6
Unintended Extubation 6 6
Drug Resistant Bacterial Infection 6 6
Pulmonary Embolism 5 5
Adult Respiratory Distress Syndrome 5 5
Shock 5 5
Rash 5 5
Skin Inflammation 5 5
Anxiety 4 4
Unspecified Gastrointestinal Problem 4 4
Respiratory Arrest 4 4
Respiratory Insufficiency 4 4
Unspecified Respiratory Problem 3 3
Constipation 3 3
Ascites 3 3
Hematemesis 3 3
Distress 3 3
Irritability 3 3
Swelling 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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