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TPLC
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show TPLC since
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2024
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Device
accessories, photographic, for endoscope (exclude light sources)
Product Code
FEM
Regulation Number
876.1500
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
5
5
2016
9
9
2017
14
14
2018
15
15
2019
22
22
2020
54
54
2021
47
47
2022
109
109
2023
131
131
2024
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
Display or Visual Feedback Problem
165
165
Break
119
119
Sparking
24
24
Smoking
17
17
Moisture Damage
17
17
Detachment of Device or Device Component
17
17
Device-Device Incompatibility
13
13
Thermal Decomposition of Device
11
11
Mechanical Problem
11
11
Use of Device Problem
11
11
Loss of Power
10
10
Unintended Movement
10
10
Fire
9
9
Melted
8
8
Difficult to Open or Close
8
8
Device Contaminated During Manufacture or Shipping
8
8
Device Operational Issue
6
6
Material Deformation
6
6
Detachment Of Device Component
6
6
Degraded
5
5
Poor Quality Image
5
5
Device Emits Odor
5
5
Device Damaged Prior to Use
5
5
Device Fell
5
5
Scratched Material
4
4
Mechanical Jam
4
4
Device Operates Differently Than Expected
4
4
Loose or Intermittent Connection
4
4
Overheating of Device
4
4
Failure to Power Up
4
4
Electrical /Electronic Property Problem
4
4
Corroded
4
4
Crack
4
4
Disconnection
3
3
Unintended Collision
3
3
Defective Component
3
3
Contamination /Decontamination Problem
3
3
Defective Device
3
3
Electrical Power Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Temperature Problem
3
3
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Difficult or Delayed Separation
2
2
Power Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Difficult to Advance
2
2
Misassembled
2
2
Fracture
2
2
Material Fragmentation
1
1
No Display/Image
1
1
Component Falling
1
1
Component Incompatible
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Device Stops Intermittently
1
1
Device Inoperable
1
1
Device Tipped Over
1
1
Device Displays Incorrect Message
1
1
Component Missing
1
1
Arcing
1
1
Electrical Shorting
1
1
Environmental Particulates
1
1
Optical Problem
1
1
Output Problem
1
1
Positioning Problem
1
1
Misassembly During Maintenance/Repair
1
1
Complete Loss of Power
1
1
Unintended Electrical Shock
1
1
Unexpected Shutdown
1
1
Data Problem
1
1
Noise, Audible
1
1
Physical Resistance/Sticking
1
1
Misassembly by Users
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
295
295
No Known Impact Or Consequence To Patient
38
38
No Consequences Or Impact To Patient
37
37
No Information
33
33
No Patient Involvement
20
20
Insufficient Information
7
7
Injury
7
7
Not Applicable
6
6
Unspecified Tissue Injury
4
4
Electric Shock
3
3
Bruise/Contusion
3
3
Patient Problem/Medical Problem
2
2
Shock
2
2
No Code Available
1
1
Bowel Perforation
1
1
Swelling
1
1
Burn(s)
1
1
Laceration(s)
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pain
1
1
Burn, Thermal
1
1
Sprain
1
1
Numbness
1
1
Hyperextension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ambu Inc.
II
Sep-22-2023
2
Olympus America Inc.
II
Mar-05-2012
3
Olympus Corporation of the Americas
II
Jul-17-2019
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