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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, percutaneous, biopsy
Product CodeMJG
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 2 2
2020 9 9
2021 6 6
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5 5
Break 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Component Misassembled 2 2
Detachment of Device or Device Component 2 2
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Misassembled 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 3 3
No Code Available 3 3
Hemorrhage/Bleeding 2 2
Pain 2 2
No Consequences Or Impact To Patient 2 2
Injury 1 1
Deformity/ Disfigurement 1 1
Needle Stick/Puncture 1 1
Pseudoaneurysm 1 1
Localized Skin Lesion 1 1
Cyst(s) 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 M.D.L. S.r.l. II Sep-20-2021
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