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TPLC
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show TPLC since
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2020
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2024
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Device
image, illumination, fiberoptic, for endoscope
Product Code
FFS
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
4
4
2016
7
7
2017
19
19
2018
19
19
2019
17
17
2020
56
56
2021
57
57
2022
10
10
2023
6
6
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
63
63
Failure to Power Up
56
56
Protective Measures Problem
16
16
Unexpected Shutdown
15
15
Insufficient Information
10
10
Power Problem
9
9
Loss of Power
7
7
Smoking
6
6
Device Displays Incorrect Message
5
5
Noise, Audible
4
4
Device Operates Differently Than Expected
3
3
Inadequate Lighting
3
3
Device Emits Odor
3
3
Electrical Shorting
3
3
Melted
3
3
Device Inoperable
3
3
Thermal Decomposition of Device
3
3
Electrical /Electronic Property Problem
2
2
Break
2
2
Fire
2
2
No Display/Image
2
2
Defective Component
2
2
No Apparent Adverse Event
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Issue
1
1
Loose or Intermittent Connection
1
1
Hole In Material
1
1
No Device Output
1
1
Image Display Error/Artifact
1
1
Poor Quality Image
1
1
Electrical Power Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Optical Obstruction
1
1
Sparking
1
1
Scratched Material
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
88
88
No Known Impact Or Consequence To Patient
56
56
No Patient Involvement
33
33
No Information
9
9
No Consequences Or Impact To Patient
9
9
Full thickness (Third Degree) Burn
3
3
No Code Available
1
1
Burn, Thermal
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Blurred Vision
1
1
Partial thickness (Second Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Jun-05-2017
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