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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
dislodger, stone, flexible
Product Code
FGO
Regulation Number
876.4680
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
15
15
2016
21
21
2017
17
17
2018
14
14
2019
25
25
2020
19
19
2021
14
14
2022
18
18
2023
14
14
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Peeled/Delaminated
52
52
Detachment of Device or Device Component
52
52
Break
25
25
Difficult to Open or Close
19
19
Detachment Of Device Component
11
11
Material Deformation
6
6
Material Frayed
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Material Split, Cut or Torn
5
5
Difficult to Remove
5
5
Sticking
3
3
Entrapment of Device
2
2
Torn Material
2
2
Device Inoperable
2
2
Packaging Problem
2
2
Device Fell
2
2
Material Twisted/Bent
2
2
Tear, Rip or Hole in Device Packaging
2
2
Material Separation
2
2
Migration or Expulsion of Device
1
1
Unsealed Device Packaging
1
1
Defective Device
1
1
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Loose or Intermittent Connection
1
1
Deformation Due to Compressive Stress
1
1
Delivered as Unsterile Product
1
1
Difficult to Advance
1
1
Degraded
1
1
Shipping Damage or Problem
1
1
Retraction Problem
1
1
Component Falling
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
87
87
No Clinical Signs, Symptoms or Conditions
51
51
No Known Impact Or Consequence To Patient
18
18
Foreign Body In Patient
6
6
Insufficient Information
5
5
No Code Available
3
3
Pain
3
3
Device Embedded In Tissue or Plaque
3
3
Discomfort
2
2
Sepsis
1
1
Hematuria
1
1
Hematoma
1
1
Inflammation
1
1
Perforation
1
1
Laceration(s) of Esophagus
1
1
Obstruction/Occlusion
1
1
Urethral Stenosis/Stricture
1
1
Injury
1
1
Unspecified Kidney or Urinary Problem
1
1
Tissue Damage
1
1
Myocardial Infarction
1
1
Hemorrhage/Bleeding
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
US Endoscopy Group Inc
II
Oct-03-2012
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