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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 2
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
CREATIVE BALLOONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK
  SUBSTANTIALLY EQUIVALENT 1
ENDOLUMIK INC.
  SUBSTANTIALLY EQUIVALENT 1
ENVIZION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAVITAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  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 2
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2020 1641 1641
2021 1652 1652
2022 1650 1650
2023 1867 1867
2024 1345 1578

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4315 4548
Break 470 470
Fluid/Blood Leak 467 467
Detachment of Device or Device Component 435 435
Obstruction of Flow 246 246
Malposition of Device 233 233
Difficult to Remove 209 209
Material Rupture 199 199
Material Split, Cut or Torn 152 152
Device Dislodged or Dislocated 143 143
Unintended Deflation 141 141
Leak/Splash 135 135
Material Puncture/Hole 135 135
Material Twisted/Bent 116 116
Fracture 88 88
Material Separation 82 82
Migration 65 65
Crack 65 65
Disconnection 64 64
Material Integrity Problem 51 51
Patient Device Interaction Problem 50 50
Material Fragmentation 47 47
Complete Blockage 47 47
Burst Container or Vessel 43 43
Deflation Problem 42 42
Inflation Problem 41 41
No Apparent Adverse Event 39 39
Use of Device Problem 37 37
Insufficient Information 33 33
Improper or Incorrect Procedure or Method 28 28
Component Missing 28 28
Device Handling Problem 28 28
Biocompatibility 27 27
Defective Device 26 26
Stretched 24 24
Separation Failure 20 20
Physical Resistance/Sticking 19 19
Decrease in Pressure 19 19
Entrapment of Device 19 19
Material Deformation 19 19
Difficult to Advance 18 18
Appropriate Term/Code Not Available 17 17
Product Quality Problem 16 16
Unintended Movement 16 16
Fitting Problem 16 16
Material Perforation 15 15
Misconnection 15 15
Loose or Intermittent Connection 14 14
Therapeutic or Diagnostic Output Failure 13 13
Positioning Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1866 1866
Skin Infection 1829 1965
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 966 1013
Unspecified Infection 588 588
Foreign Body In Patient 396 396
Insufficient Information 368 368
No Code Available 290 290
No Consequences Or Impact To Patient 290 290
Ulcer 181 181
No Known Impact Or Consequence To Patient 167 167
Pneumothorax 154 154
Bowel Perforation 141 141
Peritonitis 135 135
Hemorrhage/Bleeding 108 108
Post Operative Wound Infection 107 107
Stomach Ulceration 107 107
Pain 79 79
Perforation 76 77
Abscess 75 75
Pneumonia 70 70
Aspiration Pneumonitis 69 69
Death 57 57
Sepsis 56 56
Gastrointestinal Hemorrhage 53 54
Skin Inflammation/ Irritation 49 49
Discomfort 49 49
Pressure Sores 49 49
Tissue Breakdown 48 48
Vomiting 48 48
Abdominal Pain 47 47
Aspiration/Inhalation 43 43
Obstruction/Occlusion 40 40
Failure of Implant 38 38
Laceration(s) 33 33
No Patient Involvement 32 32
Bacterial Infection 25 25
Granuloma 25 25
Inflammation 25 25
Fluid Discharge 25 25
Device Embedded In Tissue or Plaque 25 25
Necrosis 24 24
Skin Tears 22 22
Laceration(s) of Esophagus 21 21
Unspecified Tissue Injury 21 21
Needle Stick/Puncture 20 20
Perforation of Esophagus 20 20
Fistula 20 20
Feeding Problem 18 18
Erythema 17 17
Anemia 17 17

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Technology Inc II Jun-28-2024
2 Avanos Medical, Inc. II Jul-23-2024
3 Avanos Medical, Inc. I Mar-01-2024
4 Avanos Medical, Inc. I May-13-2022
5 Avanos Medical, Inc. II Feb-07-2022
6 Avanos Medical, Inc. II Dec-07-2020
7 Avanos Medical, Inc. II Sep-17-2020
8 Boston Scientific Corporation II Apr-11-2024
9 C.R. Bard Inc II Jan-25-2024
10 Cardinal Health 200, LLC II Sep-26-2024
11 Hollister Incorporated II Mar-26-2021
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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