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TPLC
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show TPLC since
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2024
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Device
endoscope, ac-powered and accessories
Product Code
GCP
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2015
4
4
2016
13
13
2017
117
117
2018
26
26
2019
19
19
2020
18
18
2021
12
12
2022
26
26
2023
100
100
2024
48
48
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
219
219
Detachment Of Device Component
35
35
Detachment of Device or Device Component
30
30
Product Quality Problem
23
23
Mechanical Problem
21
21
Adverse Event Without Identified Device or Use Problem
20
20
Component Falling
19
19
Fracture
19
19
Material Fragmentation
18
18
Thermal Decomposition of Device
8
8
Contamination
7
7
Material Twisted/Bent
7
7
Difficult to Open or Close
7
7
Component Missing
6
6
Obstruction of Flow
5
5
Crack
5
5
Nonstandard Device
4
4
Sparking
4
4
Material Deformation
3
3
Poor Quality Image
3
3
Scratched Material
3
3
Physical Resistance/Sticking
3
3
Device Handling Problem
2
2
Mechanical Jam
2
2
Optical Problem
2
2
Device Or Device Fragments Location Unknown
2
2
Device Operates Differently Than Expected
2
2
Melted
2
2
Difficult to Fold, Unfold or Collapse
2
2
Difficult to Remove
2
2
Material Separation
2
2
Material Frayed
2
2
Image Display Error/Artifact
2
2
Material Disintegration
2
2
No Display/Image
1
1
Entrapment of Device
1
1
Fire
1
1
Flaked
1
1
Degraded
1
1
Charred
1
1
Corroded
1
1
Sticking
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Component
1
1
Retraction Problem
1
1
Failure to Transmit Record
1
1
Bent
1
1
Overheating of Device
1
1
Peeled/Delaminated
1
1
Pitted
1
1
Difficult to Advance
1
1
Communication or Transmission Problem
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contaminated During Manufacture or Shipping
1
1
Out-Of-Box Failure
1
1
Failure to Align
1
1
Dent in Material
1
1
Failure to Form Staple
1
1
Arcing
1
1
Material Split, Cut or Torn
1
1
No Apparent Adverse Event
1
1
Device Fell
1
1
Unintended Electrical Shock
1
1
Failure to Clean Adequately
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
167
167
No Consequences Or Impact To Patient
81
81
Foreign Body In Patient
39
39
No Known Impact Or Consequence To Patient
37
37
Bacterial Infection
27
27
Device Embedded In Tissue or Plaque
6
6
Injury
4
4
Burn(s)
4
4
Hemorrhage/Bleeding
3
3
Internal Organ Perforation
2
2
Tissue Damage
2
2
No Code Available
2
2
Rupture
2
2
Urinary Incontinence
2
2
Insufficient Information
2
2
Hyponatremia
1
1
Urethral Stenosis/Stricture
1
1
Burn, Thermal
1
1
Blood Loss
1
1
No Patient Involvement
1
1
Uterine Perforation
1
1
Perforation
1
1
Shock
1
1
Incontinence
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Feb-23-2018
2
Olympus Corporation of the Americas
II
Jun-26-2017
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