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TPLC
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show TPLC since
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Device
forceps
Regulation Description
Manual surgical instrument for general use.
Product Code
HTD
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
128
128
2021
156
156
2022
147
147
2023
155
155
2024
176
176
2025
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
521
521
Device-Device Incompatibility
88
88
Material Integrity Problem
83
83
Mechanical Problem
22
22
Material Fragmentation
14
14
Material Deformation
12
12
Compatibility Problem
12
12
Use of Device Problem
11
11
Material Twisted/Bent
10
10
Contamination /Decontamination Problem
9
9
Crack
6
6
No Apparent Adverse Event
6
6
Device Slipped
6
6
Entrapment of Device
5
5
Difficult to Open or Close
5
5
Material Discolored
4
4
Insufficient Information
4
4
Appropriate Term/Code Not Available
4
4
Fracture
3
3
Product Quality Problem
3
3
Detachment of Device or Device Component
2
2
Human-Device Interface Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Failure to Clean Adequately
1
1
Output Problem
1
1
Physical Resistance/Sticking
1
1
Residue After Decontamination
1
1
Unexpected Therapeutic Results
1
1
Failure to Cut
1
1
Component Missing
1
1
Noise, Audible
1
1
Nonstandard Device
1
1
Failure to Align
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
624
624
No Consequences Or Impact To Patient
66
66
Insufficient Information
37
37
No Patient Involvement
35
35
Foreign Body In Patient
7
7
No Known Impact Or Consequence To Patient
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Code Available
3
3
Needle Stick/Puncture
1
1
Burn(s)
1
1
Vascular Dissection
1
1
Tissue Damage
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Hemorrhage/Bleeding
1
1
Perforation
1
1
Osteopenia/ Osteoporosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sklar Instruments
II
Jan-16-2025
2
Stradis Medical, LLC dba Stradis Healthcare
II
Aug-18-2022
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