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TPLC
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show TPLC since
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2024
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Device
ligator, esophageal
Product Code
MND
Regulation Number
876.4400
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
294
294
2020
345
345
2021
674
674
2022
808
808
2023
689
689
2024
224
224
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Fire
2012
2012
Premature Activation
364
364
Use of Device Problem
294
294
Break
292
292
Material Integrity Problem
155
155
Detachment of Device or Device Component
119
119
Human-Device Interface Problem
80
80
Device Dislodged or Dislocated
76
76
Defective Device
59
59
Difficult or Delayed Positioning
58
58
Device Difficult to Setup or Prepare
51
51
Adverse Event Without Identified Device or Use Problem
41
41
Material Too Soft/Flexible
38
38
Material Separation
36
36
Misfire
36
36
Difficult to Remove
35
35
Premature Separation
35
35
Material Deformation
26
26
Activation, Positioning or Separation Problem
26
26
Entrapment of Device
23
23
Unintended Movement
18
18
Misassembly by Users
16
16
Difficult or Delayed Separation
15
15
Device-Device Incompatibility
15
15
Positioning Failure
10
10
Suction Problem
9
9
Separation Failure
7
7
Off-Label Use
7
7
Device Misassembled During Manufacturing /Shipping
7
7
Device Handling Problem
7
7
Material Twisted/Bent
6
6
Improper or Incorrect Procedure or Method
6
6
Fracture
6
6
Degraded
6
6
Physical Resistance/Sticking
5
5
Activation Problem
4
4
Appropriate Term/Code Not Available
4
4
Migration
4
4
Mechanical Problem
4
4
Inability to Irrigate
4
4
Component Missing
4
4
Shipping Damage or Problem
3
3
Misassembled
3
3
Unsealed Device Packaging
3
3
Accessory Incompatible
3
3
Activation Failure
3
3
Insufficient Information
3
3
Separation Problem
3
3
Device Fell
3
3
Malposition of Device
3
3
Mechanical Jam
2
2
Therapeutic or Diagnostic Output Failure
2
2
Nonstandard Device
2
2
Retraction Problem
2
2
Product Quality Problem
1
1
Failure to Disconnect
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Premature Discharge of Battery
1
1
Partial Blockage
1
1
Contamination
1
1
Fluid/Blood Leak
1
1
Packaging Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Contamination /Decontamination Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Gas/Air Leak
1
1
Failure to Clean Adequately
1
1
Material Split, Cut or Torn
1
1
Firing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2284
2284
No Consequences Or Impact To Patient
518
518
Hemorrhage/Bleeding
94
94
No Known Impact Or Consequence To Patient
85
85
No Patient Involvement
48
48
Foreign Body In Patient
48
48
Insufficient Information
30
30
Gastrointestinal Hemorrhage
28
28
Perforation
7
7
No Code Available
6
6
Peritonitis
6
6
Low Oxygen Saturation
3
3
Unspecified Tissue Injury
3
3
Swelling/ Edema
3
3
Hemostasis
3
3
Low Blood Pressure/ Hypotension
3
3
Abdominal Pain
3
3
Fever
3
3
Bradycardia
2
2
Dysphagia/ Odynophagia
2
2
Laceration(s)
2
2
Laceration(s) of Esophagus
2
2
Obstruction/Occlusion
1
1
Blood Loss
1
1
Malaise
1
1
Hypovolemia
1
1
Stenosis of the esophagus
1
1
Ischemia Stroke
1
1
Bowel Perforation
1
1
Tissue Damage
1
1
Hypoxia
1
1
Inflammation
1
1
Cardiopulmonary Arrest
1
1
Chest Pain
1
1
Death
1
1
Foreign Body Reaction
1
1
Aspiration/Inhalation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Micro-Tech Usa
II
Nov-18-2020
2
Olympus Corporation of the Americas
II
Apr-20-2023
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