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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 CORPORATION
SUBSTANTIALLY EQUIVALENT
2
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
M.I. TECH CO., LTD
SUBSTANTIALLY EQUIVALENT
2
M.I.TECH CO., LTD.
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
1
TAEWOONG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
THORACENT, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
151
151
2024
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
350
350
Activation Failure
182
182
Migration
118
118
Adverse Event Without Identified Device or Use Problem
114
114
Break
114
114
Positioning Problem
97
97
Migration or Expulsion of Device
83
83
Activation Problem
74
74
Difficult to Remove
60
60
Material Deformation
58
58
Positioning Failure
53
53
Use of Device Problem
48
48
Improper or Incorrect Procedure or Method
43
43
Fracture
41
41
Detachment of Device or Device Component
41
41
Material Integrity Problem
36
36
Insufficient Information
31
31
Off-Label Use
25
25
Appropriate Term/Code Not Available
24
24
Failure to Advance
23
23
Premature Activation
19
19
Material Twisted/Bent
13
13
Physical Resistance/Sticking
12
12
Obstruction of Flow
11
11
Material Perforation
11
11
Partial Blockage
11
11
Difficult or Delayed Positioning
10
10
Material Separation
8
8
Unraveled Material
8
8
Human-Device Interface Problem
8
8
Detachment Of Device Component
6
6
Structural Problem
5
5
Device Markings/Labelling Problem
5
5
Device Stenosis
5
5
Difficult to Advance
4
4
Difficult to Open or Close
4
4
Hole In Material
4
4
Kinked
4
4
Knotted
4
4
Component Missing
4
4
Device Issue
4
4
Unsealed Device Packaging
3
3
Infusion or Flow Problem
3
3
Delivery System Failure
3
3
Device Operates Differently Than Expected
3
3
Device Packaging Compromised
2
2
Device Or Device Fragments Location Unknown
2
2
Malposition of Device
2
2
Misfire
2
2
Device Dislodged or Dislocated
2
2
Leak/Splash
2
2
Difficult to Insert
2
2
Bent
2
2
Entrapment of Device
2
2
Material Erosion
2
2
Wrong Label
2
2
Sharp Edges
2
2
Material Split, Cut or Torn
2
2
Separation Problem
1
1
Flaked
1
1
Fluid/Blood Leak
1
1
Loss of or Failure to Bond
1
1
Material Fragmentation
1
1
Misassembled
1
1
Occlusion Within Device
1
1
Device Inoperable
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Deliver
1
1
Defective Component
1
1
Expulsion
1
1
Human Factors Issue
1
1
Packaging Problem
1
1
Torn Material
1
1
No Apparent Adverse Event
1
1
Separation Failure
1
1
Difficult or Delayed Activation
1
1
Defective Device
1
1
Dent in Material
1
1
Patient-Device Incompatibility
1
1
Deformation Due to Compressive Stress
1
1
Failure to Fire
1
1
Device-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
490
491
No Clinical Signs, Symptoms or Conditions
298
298
No Known Impact Or Consequence To Patient
103
103
No Code Available
45
45
Dysphagia/ Odynophagia
44
44
Obstruction/Occlusion
40
40
Hemorrhage/Bleeding
36
36
Perforation
28
28
Death
26
26
Pain
22
22
Erosion
21
21
Fistula
17
17
Vomiting
15
15
Insufficient Information
13
13
No Information
10
10
Dysphasia
10
10
Discomfort
10
10
Pneumonia
10
10
Abdominal Pain
9
9
Foreign Body In Patient
9
9
Chest Pain
8
8
Nausea
8
8
Occlusion
7
7
Failure of Implant
7
7
Fever
7
7
Blood Loss
7
7
Aspiration/Inhalation
6
6
Regurgitation
5
5
Injury
4
4
No Patient Involvement
4
4
Perforation of Esophagus
4
4
Gastrointestinal Hemorrhage
4
4
Cough
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Foreign body, removal of
3
3
Peritonitis
3
3
Ulcer
3
3
Laceration(s) of Esophagus
3
3
Dyspnea
3
3
Cardiac Arrest
2
2
Abrasion
2
2
Adhesion(s)
2
2
Airway Obstruction
2
2
Internal Organ Perforation
2
2
Inflammation
2
2
Excessive Tear Production
2
2
Decreased Appetite
2
2
Difficulty Chewing
2
2
Device Embedded In Tissue or Plaque
2
2
Intraoperative Pain
1
1
Hematemesis
1
1
Hernia
1
1
Impaired Healing
1
1
Stenosis
1
1
Weight Changes
1
1
Choking
1
1
Skin Tears
1
1
Laceration(s)
1
1
Unspecified Infection
1
1
Radiation Underdose
1
1
Surgery, prolonged
1
1
Pneumothorax
1
1
Pulmonary Dysfunction
1
1
Tissue Damage
1
1
Ulceration
1
1
Anemia
1
1
Arrhythmia
1
1
Host-Tissue Reaction
1
1
Erythema
1
1
Exsanguination
1
1
Foreign Body Reaction
1
1
Gastritis
1
1
Pyrosis/Heartburn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Taewoong Medical Co., Ltd.
II
Feb-14-2020
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