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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps
Regulation Description Manual surgical instrument for general use.
Product CodeHTD
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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