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TPLC
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Device
ligator, esophageal
Product Code
MND
Regulation Number
876.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
ENDOCHOICE, INC.
SUBSTANTIALLY EQUIVALENT
1
SCANDIMED INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
117
117
2015
76
76
2016
94
94
2017
88
88
2018
124
124
2019
294
294
2020
345
345
2021
674
674
2022
808
808
2023
689
689
2024
589
589
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Fire
2278
2278
Premature Activation
555
555
Break
349
349
Use of Device Problem
333
333
Material Integrity Problem
167
167
Detachment of Device or Device Component
144
144
Difficult or Delayed Positioning
97
97
Human-Device Interface Problem
94
94
Device Dislodged or Dislocated
83
83
Positioning Failure
70
70
Defective Device
63
63
Difficult to Remove
62
62
Material Separation
62
62
Device Difficult to Setup or Prepare
61
61
Adverse Event Without Identified Device or Use Problem
58
58
Migration or Expulsion of Device
57
57
Detachment Of Device Component
57
57
Activation, Positioning or Separation Problem
52
52
Material Too Soft/Flexible
42
42
Misfire
40
40
Premature Separation
39
39
Improper or Incorrect Procedure or Method
32
32
Material Deformation
32
32
Entrapment of Device
31
31
Device Operates Differently Than Expected
26
26
Device-Device Incompatibility
22
22
Fracture
21
21
Separation Failure
20
20
Unintended Movement
19
19
Misassembly by Users
16
16
Difficult or Delayed Separation
16
16
Compatibility Problem
15
15
Suction Problem
11
11
Device Handling Problem
10
10
Degraded
8
8
Off-Label Use
8
8
Mechanical Problem
8
8
Material Twisted/Bent
7
7
Device Misassembled During Manufacturing /Shipping
7
7
Difficult To Position
6
6
Shelf Life Exceeded
6
6
Mechanical Jam
6
6
Component Missing
5
5
Accessory Incompatible
5
5
Physical Resistance/Sticking
5
5
Migration
4
4
Misassembled
4
4
Inability to Irrigate
4
4
Insufficient Information
4
4
Activation Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2637
2637
No Consequences Or Impact To Patient
869
869
Foreign Body In Patient
184
184
Hemorrhage/Bleeding
128
128
No Known Impact Or Consequence To Patient
127
127
No Patient Involvement
83
83
Insufficient Information
30
30
Gastrointestinal Hemorrhage
28
28
Hemostasis
17
17
Death
16
16
Blood Loss
9
9
Perforation
8
8
No Code Available
7
7
No Information
6
6
Peritonitis
6
6
Tissue Damage
6
6
Laceration(s) of Esophagus
5
5
Abdominal Pain
4
4
Obstruction/Occlusion
4
4
Abdominal Distention
3
3
Device Embedded In Tissue or Plaque
3
3
Low Oxygen Saturation
3
3
Asthma
3
3
Low Blood Pressure/ Hypotension
3
3
Fever
3
3
Pain
3
3
Laceration(s)
3
3
Reaction
3
3
Swelling/ Edema
3
3
Unspecified Tissue Injury
3
3
Respiratory Distress
2
2
Bradycardia
2
2
Dysphagia/ Odynophagia
2
2
Distress
1
1
Hypovolemia
1
1
Ischemia Stroke
1
1
Airway Obstruction
1
1
Hypoxia
1
1
Pneumonia
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Vomiting
1
1
Stenosis of the esophagus
1
1
Injury
1
1
Foreign Body Reaction
1
1
Malaise
1
1
Aspiration/Inhalation
1
1
Inflammation
1
1
Bowel Perforation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Endoscopy
II
Jun-28-2011
2
Cook Endoscopy
II
Oct-19-2010
3
Micro-Tech Usa
II
Nov-18-2020
4
Olympus Corporation of the Americas
II
Apr-20-2023
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