Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
device, percutaneous, biopsy
Regulation Description
Manual surgical instrument for general use.
Product Code
MJG
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
9
9
2021
6
6
2023
1
1
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5
5
Material Separation
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Entrapment of Device
3
3
Device-Device Incompatibility
2
2
Detachment of Device or Device Component
2
2
Material Twisted/Bent
2
2
Component Misassembled
2
2
Device Contaminated During Manufacture or Shipping
1
1
Mechanical Problem
1
1
Mechanical Jam
1
1
Misassembled
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6
6
Foreign Body In Patient
6
6
Insufficient Information
3
3
No Code Available
3
3
Pain
2
2
Hemorrhage/Bleeding
2
2
No Consequences Or Impact To Patient
2
2
Hematoma
1
1
Deformity/ Disfigurement
1
1
Injury
1
1
No Known Impact Or Consequence To Patient
1
1
Needle Stick/Puncture
1
1
Pseudoaneurysm
1
1
Localized Skin Lesion
1
1
Cyst(s)
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
-
-