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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 3
  SUBSTANTIALLY EQUIVALENT - KIT 1
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 887 1120

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5089 5322
Fluid/Blood Leak 624 624
Detachment of Device or Device Component 571 571
Break 523 523
Obstruction of Flow 280 280
Malposition of Device 250 250
Difficult to Remove 240 240
Material Rupture 208 208
Leak/Splash 195 195
Device Dislodged or Dislocated 157 157
Material Split, Cut or Torn 148 148
Material Twisted/Bent 144 144
Material Puncture/Hole 133 133
Unintended Deflation 121 121
Fracture 88 88
Migration 85 85
Material Separation 84 84
Crack 81 81
Disconnection 77 77
Deflation Problem 77 77
Patient Device Interaction Problem 76 76
Complete Blockage 59 59
Insufficient Information 56 56
Material Integrity Problem 55 55
Burst Container or Vessel 54 54
No Apparent Adverse Event 50 50
Inflation Problem 48 48
Use of Device Problem 45 45
Material Fragmentation 42 42
Migration or Expulsion of Device 42 42
Component Missing 38 38
Physical Resistance/Sticking 31 31
Improper or Incorrect Procedure or Method 31 31
Device Handling Problem 29 29
Difficult to Advance 28 28
Defective Device 28 28
Biocompatibility 27 27
Appropriate Term/Code Not Available 24 24
Stretched 24 24
Defective Component 23 23
Entrapment of Device 22 22
Pressure Problem 20 20
Product Quality Problem 19 19
Decrease in Pressure 19 19
Separation Failure 18 18
Device Contamination with Chemical or Other Material 18 18
Material Deformation 18 18
Fitting Problem 18 18
Material Perforation 18 18
Patient-Device Incompatibility 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1745 1745
Skin Infection 1691 1827
Unspecified Infection 1025 1025
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 915 962
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 383 383
Insufficient Information 350 350
Ulcer 236 236
Post Operative Wound Infection 230 230
Pneumothorax 178 178
Peritonitis 178 178
Bowel Perforation 170 170
Hemorrhage/Bleeding 128 128
Pneumonia 114 114
Stomach Ulceration 103 103
Death 100 100
Perforation 96 97
Abscess 91 91
Pain 87 87
No Patient Involvement 73 73
Aspiration Pneumonitis 65 65
Aspiration/Inhalation 64 64
Sepsis 64 64
Tissue Breakdown 61 61
Discomfort 51 51
Gastrointestinal Hemorrhage 51 52
Pressure Sores 49 49
Obstruction/Occlusion 48 48
Vomiting 48 48
Skin Inflammation/ Irritation 47 47
Abdominal Pain 45 45
Inflammation 39 39
Laceration(s) 36 36
Failure of Implant 31 31
No Information 31 31
Device Embedded In Tissue or Plaque 30 30
Granuloma 27 27
Necrosis 27 27
Fluid Discharge 25 25
Internal Organ Perforation 24 24
Bacterial Infection 23 23
Fistula 22 22
Cellulitis 21 21
Skin Tears 21 21
Needle Stick/Puncture 20 20
Low Oxygen Saturation 20 20
Feeding Problem 19 19
Ulceration 18 18

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 Avanos Medical, Inc. II Nov-14-2019
9 Boston Scientific Corporation II Apr-11-2024
10 C.R. Bard Inc II Jan-25-2024
11 Hollister Incorporated II Mar-26-2021
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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