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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 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 3
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
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN (DBA MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
PROSYS INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESHAPE LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 3
TOOLS FOR SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 2

MDR Year MDR Reports MDR Events
2017 1672 1672
2018 1899 1899
2019 1837 1837
2020 1641 1641
2021 1652 1652
2022 982 982

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4564 4564
Fluid Leak 671 671
Break 577 577
Detachment of Device or Device Component 503 503
Insufficient Information 476 476
Leak/Splash 456 456
Difficult to Remove 218 218
Malposition of Device 184 184
Detachment Of Device Component 167 167
Deflation Problem 161 161
Device Dislodged or Dislocated 159 159
Material Rupture 142 142
Disconnection 125 125
Obstruction of Flow 120 120
Material Twisted/Bent 119 119
Material Split, Cut or Torn 99 99
Material Puncture/Hole 99 99
Crack 98 98
Migration or Expulsion of Device 85 85
Migration 82 82
Kinked 80 80
Inflation Problem 77 77
Fracture 76 76
Occlusion Within Device 70 70
Material Separation 69 69
Burst Container or Vessel 62 62
Appropriate Term/Code Not Available 55 55
Complete Blockage 53 53
Patient Device Interaction Problem 44 44
Use of Device Problem 44 44
Component Missing 40 40
Patient-Device Incompatibility 40 40
Improper or Incorrect Procedure or Method 40 40
Device Contamination with Chemical or Other Material 40 40
Device Operates Differently Than Expected 37 37
Material Perforation 36 36
Knotted 35 35
Material Integrity Problem 32 32
Physical Resistance/Sticking 31 31
Defective Component 30 30
Hole In Material 30 30
Difficult to Advance 30 30
No Apparent Adverse Event 29 29
Material Fragmentation 29 29
Entrapment of Device 26 26
Loose or Intermittent Connection 25 25
Biocompatibility 24 24
No Display/Image 24 24
Partial Blockage 24 24
Positioning Problem 23 23
Unintended Deflation 22 22
Defective Device 22 22
Material Deformation 21 21
Fitting Problem 20 20
Pressure Problem 20 20
Device Handling Problem 18 18
Difficult to Open or Close 16 16
Component Falling 16 16
Device Fell 15 15
Human-Device Interface Problem 14 14
Material Frayed 14 14
Device Markings/Labelling Problem 14 14
Split 14 14
Torn Material 14 14
Therapeutic or Diagnostic Output Failure 13 13
Degraded 13 13
Device Displays Incorrect Message 11 11
Decrease in Pressure 11 11
Product Quality Problem 11 11
Positioning Failure 10 10
Off-Label Use 10 10
Loss of Power 10 10
Separation Failure 10 10
Difficult to Insert 10 10
Difficult to Flush 10 10
Suction Problem 10 10
Retraction Problem 10 10
Deformation Due to Compressive Stress 10 10
No Flow 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Nonstandard Device 9 9
Difficult or Delayed Positioning 9 9
Volume Accuracy Problem 8 8
Device Slipped 8 8
Gas Leak 8 8
Material Too Rigid or Stiff 8 8
Inadequacy of Device Shape and/or Size 7 7
Device Contaminated During Manufacture or Shipping 7 7
Display or Visual Feedback Problem 7 7
Connection Problem 7 7
Contamination /Decontamination Problem 6 6
Insufficient Flow or Under Infusion 6 6
No Audible Alarm 6 6
Loss of or Failure to Bond 6 6
Mechanical Problem 6 6
Stretched 6 6
Unexpected Therapeutic Results 6 6
Misconnection 6 6
Material Discolored 6 6
Contamination 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1700 1700
No Consequences Or Impact To Patient 1321 1321
No Known Impact Or Consequence To Patient 1168 1168
No Code Available 1016 1016
Skin Infection 718 718
No Clinical Signs, Symptoms or Conditions 685 685
Post Operative Wound Infection 437 437
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 420 420
Ulcer 293 293
Peritonitis 240 240
No Patient Involvement 234 234
Foreign Body In Patient 214 214
Death 188 188
Pneumothorax 184 184
Insufficient Information 180 180
No Information 162 162
Pneumonia 156 156
Hemorrhage/Bleeding 151 151
Bowel Perforation 135 135
Perforation 119 119
Aspiration/Inhalation 93 93
Abscess 92 92
Pain 92 92
Sepsis 71 71
Device Embedded In Tissue or Plaque 67 67
Pressure Sores 65 65
Abdominal Pain 54 54
Obstruction/Occlusion 53 53
Inflammation 46 46
Vomiting 46 46
Discomfort 44 44
Tissue Damage 41 41
Injury 40 40
Tissue Breakdown 40 40
Stomach Ulceration 35 35
Internal Organ Perforation 32 33
Blood Loss 31 31
Laceration(s) 28 28
Fistula 28 28
Ulceration 27 27
Gastrointestinal Hemorrhage 25 25
Granuloma 25 25
Perforation of Esophagus 24 24
Necrosis 24 24
Aspiration Pneumonitis 23 23
Patient Problem/Medical Problem 22 22
Cellulitis 22 22
Cardiac Arrest 18 18
Erosion 17 17
Low Oxygen Saturation 17 17
Bacterial Infection 16 16
Respiratory Distress 16 16
Fever 16 16
Skin Irritation 15 15
Anemia 14 14
Erythema 14 14
Needle Stick/Puncture 14 14
Feeding Problem 14 14
Nausea 13 13
Low Blood Pressure/ Hypotension 12 12
Respiratory Failure 12 12
Pleural Effusion 12 12
Gastritis 12 12
Abdominal Distention 12 12
Failure of Implant 11 11
Burn(s) 11 11
Diarrhea 10 10
Tachycardia 9 9
Laceration(s) of Esophagus 9 9
Hematoma 9 9
Dyspnea 9 9
Septic Shock 9 9
Skin Erosion 8 8
Skin Inflammation 8 8
Hypoxia 8 8
Weight Changes 8 8
Skin Inflammation/ Irritation 8 8
Hypoglycemia 8 8
Fungal Infection 8 8
Unspecified Tissue Injury 7 7
Pulmonary Embolism 7 7
Skin Tears 5 5
Fluid Discharge 5 5
Swelling/ Edema 5 5
Rupture 5 5
Adult Respiratory Distress Syndrome 5 5
Purulent Discharge 4 4
Incontinence 4 4
Exposure to Body Fluids 4 4
Skin Discoloration 4 4
Thrombus 4 4
Underdose 4 4
Cough 4 4
Edema 4 4
Confusion/ Disorientation 4 4
Shock 4 4
Hypersensitivity/Allergic reaction 4 4
Swelling 4 4
Renal Failure 4 4
Occlusion 3 3

Recalls
Manufacturer Recall Class Date Posted
1 AbbVie Inc. II May-31-2017
2 Applied Medical Technology Inc III Feb-17-2017
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 CORPAK MedSystems, Inc. II May-25-2017
9 COVIDIEN LLC II Dec-11-2018
10 Cook Inc. II Mar-01-2018
11 Covidien LLC II Feb-20-2018
12 Hollister Incorporated II Mar-26-2021
13 Neomed Inc III Nov-30-2018
14 Teleflex Medical Europe Ltd II Apr-12-2018
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