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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
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
M.I. TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORACENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 167 167
2020 155 155
2021 77 77
2022 109 109
2023 155 155
2024 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 190 190
Activation Failure 137 137
Migration 134 134
Adverse Event Without Identified Device or Use Problem 103 103
Activation Problem 71 71
Detachment of Device or Device Component 60 60
Use of Device Problem 58 58
Positioning Problem 57 57
Material Deformation 53 53
Break 51 51
Improper or Incorrect Procedure or Method 46 46
Positioning Failure 35 35
Difficult to Remove 34 34
Off-Label Use 27 27
Failure to Advance 24 24
Appropriate Term/Code Not Available 21 21
Migration or Expulsion of Device 20 20
Insufficient Information 19 19
Material Integrity Problem 18 18
Material Twisted/Bent 16 16
Physical Resistance/Sticking 14 14
Obstruction of Flow 11 11
Fracture 10 10
Difficult or Delayed Positioning 10 10
Material Perforation 8 8
Device Stenosis 8 8
Premature Activation 8 8
Difficult to Advance 7 7
Human-Device Interface Problem 7 7
Structural Problem 5 5
Material Separation 4 4
Device Markings/Labelling Problem 3 3
Unsealed Device Packaging 3 3
Device-Device Incompatibility 3 3
Infusion or Flow Problem 3 3
No Apparent Adverse Event 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Wrong Label 2 2
Difficult to Insert 2 2
Unraveled Material 2 2
Material Split, Cut or Torn 2 2
Separation Problem 2 2
Component Missing 2 2
Sharp Edges 2 2
Packaging Problem 2 2
Product Quality Problem 1 1
Defective Device 1 1
Reflux within Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 364 364
No Consequences Or Impact To Patient 139 139
Obstruction/Occlusion 47 47
No Known Impact Or Consequence To Patient 43 43
No Code Available 39 39
Dysphagia/ Odynophagia 39 39
Hemorrhage/Bleeding 23 23
Pain 22 22
Perforation 17 17
Erosion 14 14
Insufficient Information 14 14
Fistula 11 11
Foreign Body In Patient 11 11
Discomfort 11 11
Pneumonia 10 10
Vomiting 10 10
Dysphasia 9 9
Death 7 7
Nausea 7 7
Failure of Implant 7 7
Occlusion 7 7
No Information 7 7
Chest Pain 7 7
Abdominal Pain 6 6
Blood Loss 6 6
Gastrointestinal Hemorrhage 5 5
Perforation of Esophagus 5 5
Aspiration/Inhalation 5 5
Regurgitation 5 5
Fever 5 5
Ulcer 4 4
Cough 3 3
Injury 3 3
Laceration(s) of Esophagus 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Peritonitis 2 2
Dyspnea 2 2
Difficulty Chewing 2 2
Airway Obstruction 2 2
Excessive Tear Production 2 2
Decreased Appetite 2 2
No Patient Involvement 1 1
Retroperitoneal Hemorrhage 1 1
Laceration(s) 1 1
Hematemesis 1 1
Anemia 1 1
Abscess 1 1
Pyrosis/Heartburn 1 1
Ulceration 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Taewoong Medical Co., Ltd. II Feb-14-2020
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