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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device punch, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 86 86
2021 68 68
2022 57 57
2023 46 46
2024 47 47
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 76 76
Device-Device Incompatibility 56 56
Material Twisted/Bent 47 47
Material Deformation 26 26
Dull, Blunt 20 20
Failure to Cut 15 15
Physical Resistance/Sticking 12 12
Naturally Worn 12 12
Packaging Problem 12 12
Material Integrity Problem 9 9
Contamination /Decontamination Problem 9 9
Material Fragmentation 9 9
Mechanical Problem 8 8
Mechanical Jam 8 8
Entrapment of Device 5 5
Compatibility Problem 4 4
Device Contaminated During Manufacture or Shipping 3 3
Loose or Intermittent Connection 3 3
Material Too Soft/Flexible 3 3
Insufficient Information 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Fracture 3 3
Illegible Information 3 3
Sharp Edges 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Unintended Movement 2 2
Off-Label Use 2 2
Component Missing 1 1
Difficult or Delayed Separation 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Crack 1 1
Deformation Due to Compressive Stress 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 208 208
No Consequences Or Impact To Patient 45 45
No Code Available 22 22
Insufficient Information 20 20
Not Applicable 12 12
Perforation of Vessels 12 12
No Known Impact Or Consequence To Patient 4 4
No Information 3 3
Laceration(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Intraoperative Pain 1 1
Joint Disorder 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Asystole 1 1
Great Vessel Perforation 1 1
Skin Tears 1 1
Hemorrhage/Bleeding 1 1
Infiltration into Tissue 1 1
Excessive Tear Production 1 1

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