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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
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
539
539
Device-Device Incompatibility
90
90
Material Integrity Problem
83
83
Mechanical Problem
23
23
Material Fragmentation
14
14
Compatibility Problem
12
12
Use of Device Problem
12
12
Material Deformation
12
12
Material Twisted/Bent
11
11
Contamination /Decontamination Problem
9
9
Device Slipped
6
6
Crack
6
6
No Apparent Adverse Event
6
6
Entrapment of Device
5
5
Difficult to Open or Close
5
5
Insufficient Information
4
4
Material Discolored
4
4
Appropriate Term/Code Not Available
4
4
Product Quality Problem
3
3
Fracture
3
3
Component Missing
2
2
Detachment of Device or Device Component
2
2
Output Problem
1
1
Physical Resistance/Sticking
1
1
Defective Component
1
1
Failure to Clean Adequately
1
1
Failure to Align
1
1
Failure to Cut
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Residue After Decontamination
1
1
Nonstandard Device
1
1
Unexpected Therapeutic Results
1
1
Human-Device Interface Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
647
647
No Consequences Or Impact To Patient
66
66
Insufficient Information
39
39
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
Vascular Dissection
1
1
Perforation
1
1
Osteopenia/ Osteoporosis
1
1
Burn(s)
1
1
Needle Stick/Puncture
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Inc
II
Mar-11-2025
2
Sklar Instruments
II
Jan-16-2025
3
Stradis Medical, LLC dba Stradis Healthcare
II
Aug-18-2022
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