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
instrument, ent manual surgical
Product Code
LRC
Regulation Number
874.4420
Device Class
1
Premarket Reviews
Manufacturer
Decision
ACCLARENT INC.
SUBSTANTIALLY EQUIVALENT
1
ACCLARENT, INC.
SUBSTANTIALLY EQUIVALENT
1
EXCELENT INC.
SUBSTANTIALLY EQUIVALENT
1
FIAGON GMBH
SUBSTANTIALLY EQUIVALENT
1
INTERSECT ENT
SUBSTANTIALLY EQUIVALENT
1
INTUIT MEDICAL PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
STRYKER ENT
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
20
20
2021
23
23
2022
25
25
2023
14
14
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
17
17
Incorrect Interpretation of Signal
16
16
Material Separation
15
15
Contamination of Device Ingredient or Reagent
15
15
Adverse Event Without Identified Device or Use Problem
14
14
Material Rupture
9
9
Detachment of Device or Device Component
8
8
Patient Device Interaction Problem
7
7
Insufficient Information
4
4
Fracture
4
4
Improper or Incorrect Procedure or Method
4
4
Material Fragmentation
3
3
Use of Device Problem
3
3
Difficult to Advance
2
2
Device Sensing Problem
2
2
Mechanical Problem
2
2
Crack
2
2
Deformation Due to Compressive Stress
2
2
Flaked
2
2
Loss of or Failure to Bond
2
2
Device Contaminated During Manufacture or Shipping
1
1
Separation Problem
1
1
Device-Device Incompatibility
1
1
Material Integrity Problem
1
1
Unsealed Device Packaging
1
1
Contamination
1
1
Deflation Problem
1
1
Retraction Problem
1
1
Off-Label Use
1
1
Physical Resistance/Sticking
1
1
Device Markings/Labelling Problem
1
1
Display or Visual Feedback Problem
1
1
Material Twisted/Bent
1
1
Positioning Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
61
61
Foreign Body In Patient
21
21
No Consequences Or Impact To Patient
16
16
No Known Impact Or Consequence To Patient
9
9
Pneumothorax
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Code Available
5
5
Insufficient Information
5
5
Cerebrospinal Fluid Leakage
4
4
Stroke/CVA
3
3
Brain Injury
3
3
No Information
3
3
Cardiac Arrest
3
3
Perforation of Vessels
3
3
Death
2
2
Hypoxia
2
2
Low Blood Pressure/ Hypotension
2
2
Hearing Impairment
1
1
Hypoventilation
1
1
Pulmonary Dysfunction
1
1
Mediastinal Shift
1
1
Aspiration/Inhalation
1
1
Asthma
1
1
Epistaxis
1
1
Paralysis
1
1
No Patient Involvement
1
1
Pain
1
1
Overinflation of Lung
1
1
Coma
1
1
Myocardial Infarction
1
1
Tissue Damage
1
1
Convulsion/Seizure
1
1
Hemorrhage/Bleeding
1
1
Loss of Vision
1
1
Loss of consciousness
1
1
Airway Obstruction
1
1
Internal Organ Perforation
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
II
Apr-03-2024
2
Karl Storz Endoscopy
II
Dec-18-2023
-
-