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
Premarket Reviews
Manufacturer
Decision
KARL STORZ ENDOSCOPY-AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
2
NOVAPROBE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
OLIVE MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
SUBSTANTIALLY EQUIVALENT
1
1. K121724
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
SUNOPTIC TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
23
23
2016
29
29
2017
59
59
2018
76
76
2019
118
118
2020
152
152
2021
147
147
2022
166
166
2023
179
179
2024
41
41
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
163
163
Overheating of Device
151
151
Smoking
89
89
Temperature Problem
80
80
Device Emits Odor
70
70
Circuit Failure
67
67
Electrical /Electronic Property Problem
56
56
Thermal Decomposition of Device
54
54
Display or Visual Feedback Problem
49
49
Adverse Event Without Identified Device or Use Problem
42
42
No Display/Image
40
40
Melted
38
38
Failure to Power Up
33
33
Break
32
32
Power Problem
29
29
Poor Quality Image
27
27
Loss of Power
23
23
Fire
20
20
Intermittent Continuity
19
19
Sparking
16
16
Detachment of Device or Device Component
16
16
Optical Problem
15
15
Intermittent Loss of Power
15
15
Device Operates Differently Than Expected
11
11
Use of Device Problem
11
11
Mechanical Problem
11
11
Unexpected Shutdown
9
9
Excessive Heating
8
8
Insufficient Information
7
7
Noise, Audible
7
7
Loose or Intermittent Connection
7
7
Connection Problem
7
7
Electrical Shorting
6
6
Failure to Shut Off
6
6
No Device Output
6
6
Computer Software Problem
6
6
Crack
5
5
Flare or Flash
5
5
Environmental Particulates
5
5
Device Dislodged or Dislocated
5
5
Electrical Power Problem
4
4
Environmental Compatibility Problem
4
4
Energy Output Problem
4
4
Device Contaminated During Manufacture or Shipping
4
4
Appropriate Term/Code Not Available
4
4
Device Fell
4
4
Material Integrity Problem
3
3
Erratic or Intermittent Display
3
3
Disconnection
3
3
Component Falling
3
3
Device-Device Incompatibility
3
3
Application Program Problem
3
3
Blocked Connection
3
3
Improper or Incorrect Procedure or Method
3
3
Defective Device
3
3
Device Displays Incorrect Message
3
3
Device Inoperable
3
3
Arcing
2
2
Activation, Positioning or Separation Problem
2
2
Unintended Power Up
2
2
Material Discolored
2
2
Output above Specifications
2
2
Hole In Material
2
2
Light Interference
2
2
Human-Device Interface Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Unintended Movement
2
2
Complete Loss of Power
2
2
Device Handling Problem
2
2
Intermittent Energy Output
2
2
Separation Problem
2
2
Premature Separation
1
1
Illegible Information
1
1
Intermittent Communication Failure
1
1
Reset Problem
1
1
Patient Device Interaction Problem
1
1
Explosion
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Inadequate Lighting
1
1
Mechanical Jam
1
1
Mechanics Altered
1
1
Optical Obstruction
1
1
Image Display Error/Artifact
1
1
Material Frayed
1
1
Peeled/Delaminated
1
1
Power Conditioning Problem
1
1
Positioning Failure
1
1
Material Disintegration
1
1
Component Incompatible
1
1
Detachment Of Device Component
1
1
Device Alarm System
1
1
No Audible Alarm
1
1
Device Sensing Problem
1
1
Component or Accessory Incompatibility
1
1
Loss of Data
1
1
Device Contamination with Chemical or Other Material
1
1
Material Puncture/Hole
1
1
Material Separation
1
1
Ambient Noise Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
497
497
No Known Impact Or Consequence To Patient
237
237
No Consequences Or Impact To Patient
133
133
Insufficient Information
67
67
Burn(s)
60
60
No Patient Involvement
26
26
Burn, Thermal
17
17
Superficial (First Degree) Burn
14
14
Not Applicable
11
11
No Information
8
8
Injury
5
5
Partial thickness (Second Degree) Burn
4
4
No Code Available
3
3
Patient Problem/Medical Problem
2
2
Full thickness (Third Degree) Burn
2
2
Foreign Body In Patient
1
1
Unspecified Tissue Injury
1
1
Electric Shock
1
1
Discharge
1
1
Erythema
1
1
Scarring
1
1
Shock
1
1
Swelling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Dec-02-2011
2
Integra LifeSciences Corp.
II
Apr-25-2011
3
Stryker Corporation
II
Apr-28-2023
-
-