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TPLC
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Device
prosthesis, esophageal
Product Code
ESW
Regulation Number
878.3610
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
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
109
109
2023
152
152
2024
56
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
411
411
Activation Failure
201
201
Break
129
129
Adverse Event Without Identified Device or Use Problem
127
127
Migration
122
122
Positioning Problem
113
113
Migration or Expulsion of Device
112
112
Difficult to Remove
77
77
Activation Problem
74
74
Material Deformation
70
70
Detachment of Device or Device Component
57
57
Positioning Failure
54
54
Use of Device Problem
50
50
Material Integrity Problem
49
49
Improper or Incorrect Procedure or Method
46
46
Fracture
41
41
Insufficient Information
32
32
Off-Label Use
26
26
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
Difficult to Advance
4
4
Knotted
4
4
Device Operates Differently Than Expected
4
4
Device Issue
4
4
Delivery System Failure
3
3
Device-Device Incompatibility
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
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
321
321
No Known Impact Or Consequence To Patient
132
132
Dysphagia/ Odynophagia
54
54
No Code Available
50
50
Obstruction/Occlusion
45
45
Hemorrhage/Bleeding
44
44
Death
36
36
Perforation
35
35
Pain
24
24
Erosion
23
23
Fistula
19
19
Vomiting
17
17
Insufficient Information
14
14
Foreign Body In Patient
12
12
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
Perforation of Esophagus
5
5
Regurgitation
5
5
Injury
4
4
Foreign body, removal of
4
4
No Patient Involvement
4
4
Ulcer
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
Abscess
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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