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TPLC
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show TPLC since
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Device
dilator, esophageal
Product Code
KNQ
Regulation Number
876.5365
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
1
COOK ENDOSCOPY
SUBSTANTIALLY EQUIVALENT
1
ETHICON ENDO-SURGERY, INC.
SUBSTANTIALLY EQUIVALENT
1
SAFESTITCH MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
164
164
2015
204
204
2016
154
164
2017
231
231
2018
396
396
2019
388
388
2020
364
364
2021
351
351
2022
274
274
2023
319
319
2024
184
184
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
738
740
Material Rupture
686
686
Material Puncture/Hole
300
300
Deflation Problem
203
203
Use of Device Problem
191
198
Fluid/Blood Leak
160
160
Leak/Splash
147
147
Fracture
135
135
Hole In Material
118
120
Crack
116
122
Break
82
82
Adverse Event Without Identified Device or Use Problem
78
78
Detachment Of Device Component
76
76
Difficult to Remove
67
67
Detachment of Device or Device Component
65
65
Material Deformation
59
59
Inflation Problem
52
52
Failure to Deflate
51
51
Off-Label Use
44
44
Material Twisted/Bent
44
44
Improper or Incorrect Procedure or Method
39
39
Material Fragmentation
34
34
Bent
25
25
Material Integrity Problem
18
18
Tear, Rip or Hole in Device Packaging
17
17
Material Separation
17
17
Delivered as Unsterile Product
10
10
Contamination /Decontamination Problem
10
10
Torn Material
9
9
Device-Device Incompatibility
8
8
Appropriate Term/Code Not Available
8
8
Unsealed Device Packaging
8
8
Physical Resistance/Sticking
7
7
Entrapment of Device
7
7
Deformation Due to Compressive Stress
7
7
Failure to Advance
6
6
Retraction Problem
6
6
Difficult to Advance
6
6
Device Operates Differently Than Expected
5
5
Kinked
5
5
Device Dislodged or Dislocated
4
4
Material Split, Cut or Torn
4
4
Loss of or Failure to Bond
4
4
Insufficient Information
4
4
Device Packaging Compromised
4
4
Defective Device
4
4
Packaging Problem
4
4
Device Damaged by Another Device
4
4
Material Perforation
4
4
Shipping Damage or Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1608
1618
No Clinical Signs, Symptoms or Conditions
1056
1056
No Known Impact Or Consequence To Patient
166
166
Foreign Body In Patient
48
48
No Patient Involvement
48
48
Device Embedded In Tissue or Plaque
27
27
Perforation
27
27
Insufficient Information
23
23
Perforation of Esophagus
18
18
Laceration(s) of Esophagus
14
14
Hemorrhage/Bleeding
11
11
No Information
11
11
No Code Available
8
8
Gastrointestinal Hemorrhage
6
6
Aspiration/Inhalation
6
6
Tissue Damage
4
4
Laceration(s)
4
4
Injury
4
4
Chest Pain
4
4
Death
3
3
Unspecified Tissue Injury
3
3
Intimal Dissection
2
2
Low Oxygen Saturation
2
2
Cough
2
2
Blood Loss
2
2
Pancreatitis
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Abdominal Pain
2
2
Needle Stick/Puncture
1
1
Fever
1
1
Obstruction/Occlusion
1
1
Nerve Damage
1
1
Vomiting
1
1
Discomfort
1
1
Hemostasis
1
1
Pain
1
1
Abscess
1
1
Inflammation
1
1
Bowel Perforation
1
1
Perforation of Vessels
1
1
Anxiety
1
1
Unspecified Gastrointestinal Problem
1
1
Hypoxia
1
1
Pneumothorax
1
1
Patient Problem/Medical Problem
1
1
Fistula
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
III
Jul-10-2013
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