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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device device, biopsy, endomyocardial
Regulation Description Endomyocardial biopsy device.
Product CodeDWZ
Regulation Number 870.4075
Device Class 2


Premarket Reviews
ManufacturerDecision
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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Difficult to Open or Close 5 5
Mechanical Problem 3 3
Break 2 2
Fracture 1 1
Difficult to Remove 1 1
Component Missing 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanical Jam 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Corroded 1 1
Sticking 1 1
Malposition of Device 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 4 4
Cardiac Tamponade 4 4
Perforation of Vessels 3 3
Pericardial Effusion 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Code Available 2 2
Ventricular Fibrillation 1 1
Foreign Body In Patient 1 1
No Information 1 1
Vessel Or Plaque, Device Embedded In 1 1

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