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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
forceps, biopsy, gynecological
Product Code
HFB
Regulation Number
884.4530
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
1
1
2016
1
1
2018
8
8
2019
6
6
2020
11
11
2021
8
8
2022
3
3
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Open or Close
11
11
Mechanical Problem
6
6
Failure to Deliver Energy
4
4
Defective Device
4
4
Mechanical Jam
3
3
Break
3
3
Failure to Cut
3
3
Physical Resistance/Sticking
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Separation
2
2
Failure to Fire
2
2
Activation, Positioning or Separation Problem
2
2
Dull, Blunt
2
2
Failure to Obtain Sample
1
1
Mechanics Altered
1
1
Material Deformation
1
1
Sticking
1
1
Difficult to Remove
1
1
Retraction Problem
1
1
Detachment Of Device Component
1
1
Flaked
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
16
16
No Clinical Signs, Symptoms or Conditions
8
8
Pain
7
7
Hemorrhage/Bleeding
4
4
No Consequences Or Impact To Patient
3
3
Discomfort
2
2
Injury
2
2
Insufficient Information
2
2
Blood Loss
2
2
Laceration(s)
1
1
Skin Tears
1
1
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