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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, esophageal
Product CodeESW
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORACENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 169 169
2015 175 175
2016 153 153
2017 87 87
2018 86 86
2019 167 167
2020 155 155
2021 77 77
2022 108 108
2023 152 152
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 407 407
Activation Failure 200 200
Adverse Event Without Identified Device or Use Problem 127 127
Break 127 127
Migration 121 121
Migration or Expulsion of Device 112 112
Positioning Problem 111 111
Difficult to Remove 77 77
Activation Problem 74 74
Material Deformation 70 70
Positioning Failure 53 53
Use of Device Problem 49 49
Material Integrity Problem 49 49
Detachment of Device or Device Component 46 46
Improper or Incorrect Procedure or Method 44 44
Fracture 41 41
Insufficient Information 32 32
Off-Label Use 25 25
Appropriate Term/Code Not Available 24 24
Failure to Advance 23 23
Partial Blockage 21 21
Premature Activation 19 19
Material Twisted/Bent 13 13
Physical Resistance/Sticking 12 12
Obstruction of Flow 11 11
Material Perforation 11 11
Detachment Of Device Component 11 11
Difficult or Delayed Positioning 10 10
Unraveled Material 8 8
Component Missing 8 8
Material Separation 8 8
Human-Device Interface Problem 8 8
Structural Problem 6 6
Device Markings/Labelling Problem 5 5
Torn Material 5 5
Difficult to Open or Close 5 5
Hole In Material 5 5
Kinked 5 5
Device Stenosis 5 5
Knotted 4 4
Difficult to Advance 4 4
Device Operates Differently Than Expected 4 4
Device Issue 4 4
Delivery System Failure 3 3
Infusion or Flow Problem 3 3
Bent 3 3
Unsealed Device Packaging 3 3
Leak/Splash 2 2
Difficult to Insert 2 2
Material Fragmentation 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Packaging Problem 2 2
Defective Device 2 2
Device Or Device Fragments Location Unknown 2 2
Device Dislodged or Dislocated 2 2
Misfire 2 2
Device Packaging Compromised 2 2
Malposition of Device 2 2
Wrong Label 2 2
Sharp Edges 2 2
Material Split, Cut or Torn 2 2
Separation Problem 1 1
Delivery System Issue, No Description 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Device-Device Incompatibility 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Dent in Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Expulsion 1 1
Human Factors Issue 1 1
Failure to Fire 1 1
No Apparent Adverse Event 1 1
Flaked 1 1
Fluid/Blood Leak 1 1
Loss of or Failure to Bond 1 1
Misassembled 1 1
Occlusion Within Device 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Tip breakage 1 1
Device Inoperable 1 1
Failure to Deliver 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 591 592
No Clinical Signs, Symptoms or Conditions 303 303
No Known Impact Or Consequence To Patient 132 132
Dysphagia/ Odynophagia 52 52
No Code Available 50 50
Hemorrhage/Bleeding 44 44
Obstruction/Occlusion 42 42
Death 36 36
Perforation 35 35
Erosion 23 23
Pain 23 23
Fistula 19 19
Vomiting 17 17
Insufficient Information 14 14
Foreign Body In Patient 11 11
No Information 11 11
Dysphasia 10 10
Discomfort 10 10
Pneumonia 10 10
Nausea 9 9
Abdominal Pain 9 9
Chest Pain 9 9
Fever 8 8
Blood Loss 8 8
Aspiration/Inhalation 7 7
Occlusion 7 7
Failure of Implant 7 7
Regurgitation 5 5
Injury 4 4
Foreign body, removal of 4 4
Ulcer 4 4
No Patient Involvement 4 4
Perforation of Esophagus 4 4
Gastrointestinal Hemorrhage 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cough 3 3
Laceration(s) of Esophagus 3 3
Peritonitis 3 3
Tissue Damage 3 3
Dyspnea 3 3
Abrasion 2 2
Adhesion(s) 2 2
Airway Obstruction 2 2
Cardiac Arrest 2 2
Arrhythmia 2 2
Internal Organ Perforation 2 2
Unspecified Infection 2 2
Inflammation 2 2
Stenosis 2 2
Surgery, prolonged 2 2
Excessive Tear Production 2 2
Difficulty Chewing 2 2
Device Embedded In Tissue or Plaque 2 2
Decreased Appetite 2 2
Hematemesis 1 1
Cancer 1 1
Intraoperative Pain 1 1
Bowel Perforation 1 1
Weight Changes 1 1
Choking 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Surgical procedure, delayed 1 1
Hernia 1 1
Migration 1 1
Radiation Underdose 1 1
Impaired Healing 1 1
Laceration(s) 1 1
Foreign Body Reaction 1 1
Gastritis 1 1
Pyrosis/Heartburn 1 1
Hemoptysis 1 1
Ulceration 1 1
Pneumothorax 1 1
Pulmonary Dysfunction 1 1
Host-Tissue Reaction 1 1
Anemia 1 1
Erythema 1 1
Exsanguination 1 1
Asphyxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-31-2010
2 Boston Scientific Corporation II Jun-25-2010
3 Taewoong Medical Co., Ltd. II Feb-14-2020
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