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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
2019 2 2
2020 9 9
2021 6 6
2023 1 1
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Material Separation 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Entrapment of Device 3 3
Device-Device Incompatibility 2 2
Material Twisted/Bent 2 2
Detachment of Device or Device Component 2 2
Component Misassembled 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Misassembled 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 6
No Code Available 3 3
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
Hemorrhage/Bleeding 2 2
No Consequences Or Impact To Patient 2 2
Cyst(s) 1 1
Hematoma 1 1
Localized Skin Lesion 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Pseudoaneurysm 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Incorporated II Apr-12-2024
2 M.D.L. S.r.l. II Sep-20-2021
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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