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
light source, fiberoptic, routine
Product Code
FCW
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
118
118
2020
152
152
2021
147
147
2022
166
166
2023
179
179
2024
55
55
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
165
165
Overheating of Device
118
118
Circuit Failure
72
72
Temperature Problem
66
66
Smoking
56
56
Device Emits Odor
54
54
Display or Visual Feedback Problem
52
52
Electrical /Electronic Property Problem
51
51
No Display/Image
41
41
Adverse Event Without Identified Device or Use Problem
30
30
Failure to Power Up
30
30
Break
29
29
Poor Quality Image
27
27
Melted
27
27
Power Problem
20
20
Intermittent Continuity
18
18
Detachment of Device or Device Component
16
16
Optical Problem
15
15
Intermittent Loss of Power
15
15
Thermal Decomposition of Device
13
13
Sparking
12
12
Use of Device Problem
11
11
Mechanical Problem
11
11
Loss of Power
11
11
Unexpected Shutdown
9
9
Device Contaminated During Manufacture or Shipping
7
7
Excessive Heating
7
7
Connection Problem
7
7
No Device Output
6
6
Computer Software Problem
6
6
Loose or Intermittent Connection
5
5
Failure to Shut Off
5
5
Crack
5
5
Noise, Audible
5
5
Electrical Shorting
5
5
Environmental Compatibility Problem
4
4
Environmental Particulates
4
4
Insufficient Information
4
4
Electrical Power Problem
4
4
Device Fell
4
4
Flare or Flash
4
4
Energy Output Problem
4
4
Fire
3
3
Appropriate Term/Code Not Available
3
3
Defective Device
3
3
Blocked Connection
3
3
Erratic or Intermittent Display
3
3
Device Damaged Prior to Use
3
3
Application Program Problem
3
3
Device Handling Problem
2
2
Unintended Movement
2
2
Complete Loss of Power
2
2
Disconnection
2
2
Separation Problem
2
2
Activation, Positioning or Separation Problem
2
2
Intermittent Energy Output
2
2
Therapeutic or Diagnostic Output Failure
2
2
Output above Specifications
2
2
Unintended Power Up
2
2
Human-Device Interface Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Material Integrity Problem
2
2
Loss of Data
1
1
Defective Component
1
1
Material Discolored
1
1
Electro-Static Discharge
1
1
Power Conditioning Problem
1
1
Illegible Information
1
1
Material Frayed
1
1
Explosion
1
1
Optical Obstruction
1
1
Intermittent Communication Failure
1
1
Material Puncture/Hole
1
1
No Audible Alarm
1
1
Failure to Align
1
1
Premature Separation
1
1
Mechanics Altered
1
1
Device Alarm System
1
1
Device Contamination with Chemical or Other Material
1
1
Arcing
1
1
Reset Problem
1
1
Fitting Problem
1
1
Physical Resistance/Sticking
1
1
Image Display Error/Artifact
1
1
Device-Device Incompatibility
1
1
Positioning Failure
1
1
Material Separation
1
1
Fumes or Vapors
1
1
Component Incompatible
1
1
Component or Accessory Incompatibility
1
1
Mechanical Jam
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
511
511
No Known Impact Or Consequence To Patient
133
133
No Consequences Or Impact To Patient
83
83
Insufficient Information
67
67
Burn(s)
44
44
No Patient Involvement
16
16
Superficial (First Degree) Burn
14
14
Not Applicable
11
11
Burn, Thermal
9
9
Patient Problem/Medical Problem
2
2
Partial thickness (Second Degree) Burn
2
2
Full thickness (Third Degree) Burn
2
2
Electric Shock
1
1
Shock
1
1
No Code Available
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Corporation
II
Apr-28-2023
-
-