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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
device, biopsy, endomyocardial
Product Code
DWZ
Regulation Number
870.4075
Device Class
2
Premarket Reviews
Manufacturer
Decision
FEHLING INSTRUMENTS GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2017
4
4
2018
7
7
2019
5
5
2020
5
5
2021
5
5
2022
14
14
2023
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
14
14
Difficult to Open or Close
7
7
Break
7
7
Physical Resistance/Sticking
5
5
Mechanical Problem
4
4
Difficult to Remove
3
3
Mechanical Jam
3
3
Mechanics Altered
2
2
Therapeutic or Diagnostic Output Failure
2
2
Activation Failure
2
2
Fracture
2
2
Failure to Obtain Sample
2
2
Detachment of Device or Device Component
2
2
Device Operates Differently Than Expected
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Contamination with Chemical or Other Material
1
1
Output Problem
1
1
Packaging Problem
1
1
Protective Measures Problem
1
1
Defective Device
1
1
Malposition of Device
1
1
Corroded
1
1
Sticking
1
1
Defective Component
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
Insufficient Information
7
7
No Known Impact Or Consequence To Patient
7
7
Cardiac Tamponade
6
6
No Consequences Or Impact To Patient
4
4
Cardiac Perforation
4
4
Pericardial Effusion
3
3
Perforation of Vessels
3
3
Tachycardia
2
2
No Code Available
2
2
Ventricular Fibrillation
1
1
Vessel Or Plaque, Device Embedded In
1
1
Arrhythmia
1
1
Discomfort
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Unspecified Tissue Injury
1
1
Foreign Body In Patient
1
1
No Information
1
1
-
-