Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
endoscope, ac-powered and accessories
Product Code
GCP
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
18
18
2021
12
12
2022
26
26
2023
100
100
2024
98
98
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
129
129
Detachment of Device or Device Component
31
31
Adverse Event Without Identified Device or Use Problem
18
18
Contamination
12
12
Mechanical Problem
11
11
Fracture
11
11
Material Fragmentation
9
9
Crack
8
8
Material Twisted/Bent
8
8
Thermal Decomposition of Device
8
8
Difficult to Open or Close
5
5
Device Reprocessing Problem
5
5
Labelling, Instructions for Use or Training Problem
5
5
Obstruction of Flow
5
5
Material Deformation
5
5
Physical Resistance/Sticking
4
4
Poor Quality Image
4
4
Component Missing
4
4
Sparking
3
3
Loose or Intermittent Connection
3
3
Scratched Material
3
3
Material Frayed
2
2
Electrical /Electronic Property Problem
2
2
Image Display Error/Artifact
2
2
Material Disintegration
2
2
Difficult to Fold, Unfold or Collapse
2
2
Melted
2
2
Material Separation
2
2
Degraded
2
2
Optical Problem
2
2
Mechanical Jam
1
1
Arcing
1
1
Failure to Disinfect
1
1
Corroded
1
1
Failure to Form Staple
1
1
Retraction Problem
1
1
Device Handling Problem
1
1
Pitted
1
1
Dent in Material
1
1
Failure to Align
1
1
Use of Device Problem
1
1
Difficult to Remove
1
1
Failure to Clean Adequately
1
1
Material Integrity Problem
1
1
Defective Component
1
1
Electro-Static Discharge
1
1
Device Fell
1
1
Difficult to Advance
1
1
Unintended Electrical Shock
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
207
207
Foreign Body In Patient
12
12
No Known Impact Or Consequence To Patient
10
10
No Consequences Or Impact To Patient
10
10
Sepsis
5
5
Urinary Tract Infection
5
5
Bacterial Infection
4
4
Burn(s)
3
3
Device Embedded In Tissue or Plaque
3
3
Urethral Stenosis/Stricture
3
3
Urinary Incontinence
2
2
Insufficient Information
2
2
Tissue Damage
2
2
Rupture
2
2
Hemorrhage/Bleeding
2
2
Internal Organ Perforation
2
2
Perforation
1
1
Uterine Perforation
1
1
Shock
1
1
Burn, Thermal
1
1
Blood Loss
1
1
No Patient Involvement
1
1
No Code Available
1
1
Hyponatremia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Nov-08-2024
-
-