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TPLC
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show TPLC since
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Device
blade, scalpel
Regulation Description
Manual surgical instrument for general use.
Product Code
GES
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
35
35
2021
35
35
2022
21
21
2023
28
28
2024
33
33
2025
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
56
56
Dull, Blunt
16
16
Insufficient Information
14
14
Fracture
12
12
Material Integrity Problem
9
9
Unsealed Device Packaging
7
7
Failure to Cut
6
6
Difficult to Remove
3
3
Packaging Problem
3
3
Difficult to Open or Close
3
3
Fail-Safe Did Not Operate
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Handling Problem
2
2
Degraded
2
2
Entrapment of Device
2
2
Defective Component
1
1
Material Too Soft/Flexible
1
1
Extra Components
1
1
Delivered as Unsterile Product
1
1
Material Discolored
1
1
Difficult to Open or Remove Packaging Material
1
1
Material Separation
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Appropriate Term/Code Not Available
1
1
Material Fragmentation
1
1
Contamination /Decontamination Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Nonstandard Device
1
1
Material Too Rigid or Stiff
1
1
Defective Device
1
1
Product Quality Problem
1
1
No Apparent Adverse Event
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment of Device or Device Component
1
1
Structural Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
96
96
Insufficient Information
18
18
Foreign Body In Patient
14
14
No Known Impact Or Consequence To Patient
8
8
Laceration(s)
6
6
No Consequences Or Impact To Patient
4
4
Device Embedded In Tissue or Plaque
3
3
Injury
3
3
Hemorrhage/Bleeding
1
1
Tissue Damage
1
1
Nervous System Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Southmedic, Inc.
II
Nov-23-2022
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