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TPLC
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show TPLC since
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2024
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Device
endoscope, ac-powered and accessories
Product Code
GCP
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
18
18
2021
12
12
2022
26
26
2023
100
100
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
94
94
Detachment of Device or Device Component
26
26
Adverse Event Without Identified Device or Use Problem
16
16
Fracture
10
10
Mechanical Problem
10
10
Material Fragmentation
8
8
Contamination
7
7
Crack
5
5
Obstruction of Flow
5
5
Material Twisted/Bent
5
5
Difficult to Open or Close
4
4
Material Deformation
3
3
Physical Resistance/Sticking
3
3
Material Separation
2
2
Difficult to Fold, Unfold or Collapse
2
2
Component Missing
2
2
Thermal Decomposition of Device
2
2
Material Frayed
2
2
Image Display Error/Artifact
2
2
Melted
2
2
Poor Quality Image
2
2
Peeled/Delaminated
1
1
Pitted
1
1
Difficult to Remove
1
1
Retraction Problem
1
1
Corroded
1
1
Material Disintegration
1
1
No Display/Image
1
1
Entrapment of Device
1
1
Fire
1
1
Use of Device Problem
1
1
Defective Component
1
1
Failure to Align
1
1
Failure to Form Staple
1
1
Arcing
1
1
Sparking
1
1
Device Contaminated During Manufacture or Shipping
1
1
Difficult to Advance
1
1
Optical Problem
1
1
Device Handling Problem
1
1
Material Split, Cut or Torn
1
1
Device Fell
1
1
Unintended Electrical Shock
1
1
Failure to Clean Adequately
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
140
140
Foreign Body In Patient
12
12
No Known Impact Or Consequence To Patient
10
10
No Consequences Or Impact To Patient
10
10
Bacterial Infection
4
4
Device Embedded In Tissue or Plaque
3
3
Tissue Damage
2
2
Urinary Incontinence
2
2
Insufficient Information
2
2
Burn(s)
2
2
Hemorrhage/Bleeding
2
2
Rupture
2
2
Burn, Thermal
1
1
Blood Loss
1
1
No Patient Involvement
1
1
Perforation
1
1
Shock
1
1
Uterine Perforation
1
1
No Code Available
1
1
Hyponatremia
1
1
Urethral Stenosis/Stricture
1
1
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