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TPLC
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Device
cutter, surgical
Regulation Description
Manual surgical instrument for general use.
Product Code
FZT
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
59
59
2021
63
63
2022
76
76
2023
60
60
2024
84
84
2025
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
172
172
Mechanical Jam
58
58
Difficult to Open or Close
41
41
Use of Device Problem
36
36
Break
27
27
Dull, Blunt
24
24
Material Deformation
19
19
Material Integrity Problem
11
11
Device-Device Incompatibility
9
9
Mechanical Problem
9
9
Corroded
6
6
Component Missing
5
5
No Apparent Adverse Event
3
3
Appropriate Term/Code Not Available
3
3
Defective Device
2
2
Material Twisted/Bent
2
2
Failure to Cut
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Failure to Fire
2
2
Premature Activation
2
2
Fitting Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Split, Cut or Torn
1
1
Device Damaged Prior to Use
1
1
Difficult to Advance
1
1
No Fail-Safe Mechanism
1
1
Sharp Edges
1
1
Material Rupture
1
1
Product Quality Problem
1
1
Detachment of Device or Device Component
1
1
Firing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
308
308
No Consequences Or Impact To Patient
47
47
Not Applicable
3
3
Foreign Body In Patient
2
2
Hematoma
1
1
No Known Impact Or Consequence To Patient
1
1
Laceration(s)
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sklar Instruments
II
Jan-16-2025
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