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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 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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