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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
retractor, fiberoptic
Product Code
FDG
Regulation Number
876.4530
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
5
5
2016
7
7
2017
5
5
2018
3
3
2019
3
3
2020
3
3
2022
4
4
2023
2
2
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
6
6
Insufficient Information
6
6
Break
5
5
Melted
5
5
Smoking
4
4
Temperature Problem
4
4
Use of Device Problem
3
3
Component Falling
3
3
Device Operates Differently Than Expected
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Thermal Decomposition of Device
2
2
Power Problem
2
2
Fumes or Vapors
1
1
Material Frayed
1
1
Crack
1
1
Peeled/Delaminated
1
1
Accessory Incompatible
1
1
Device Dislodged or Dislocated
1
1
Metal Shedding Debris
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
12
12
No Known Impact Or Consequence To Patient
7
7
No Clinical Signs, Symptoms or Conditions
5
5
Burn, Thermal
4
4
Partial thickness (Second Degree) Burn
3
3
Patient Problem/Medical Problem
2
2
No Code Available
2
2
No Consequences Or Impact To Patient
2
2
Superficial (First Degree) Burn
1
1
Laceration(s) of Esophagus
1
1
Blister
1
1
Foreign Body In Patient
1
1
Injury
1
1
Erythema
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Lumitex Inc
II
Sep-03-2009
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