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TPLC
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Device
instrument, ent manual surgical
Product Code
LRC
Regulation Number
874.4420
Device Class
1
Premarket Reviews
Manufacturer
Decision
3NT MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
ACCLARENT INC.
SUBSTANTIALLY EQUIVALENT
1
ACCLARENT, INC.
SUBSTANTIALLY EQUIVALENT
6
ENTELLUS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
EXCELENT INC.
SUBSTANTIALLY EQUIVALENT
1
FIAGON GMBH
SUBSTANTIALLY EQUIVALENT
1
INTERSECT ENT
SUBSTANTIALLY EQUIVALENT
1
INTUIT MEDICAL PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
2
M/S. MERIL LIFE SCIENCES PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC XOMED, INC.
SUBSTANTIALLY EQUIVALENT
1
SINUSYS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
STRYKER ENT
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
41
41
2016
39
39
2017
32
32
2018
42
42
2019
19
19
2020
20
20
2021
23
23
2022
25
25
2023
14
14
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
53
53
Break
33
33
Material Rupture
21
21
Material Separation
20
20
Detachment of Device or Device Component
17
17
Incorrect Interpretation of Signal
14
14
Detachment Of Device Component
9
9
Material Fragmentation
7
7
Unsealed Device Packaging
6
6
Insufficient Information
6
6
Material Frayed
6
6
Use of Device Problem
6
6
Fracture
6
6
Burst Container or Vessel
5
5
Bent
5
5
Improper or Incorrect Procedure or Method
5
5
Scratched Material
5
5
Imprecision
5
5
Patient Device Interaction Problem
5
5
Device Operates Differently Than Expected
4
4
Tear, Rip or Hole in Device Packaging
3
3
Material Integrity Problem
3
3
Deflation Problem
3
3
Component Falling
3
3
Crack
3
3
Mechanical Problem
2
2
Fluid/Blood Leak
2
2
Temperature Problem
2
2
Aborted Charge
2
2
Difficult to Advance
2
2
Flaked
2
2
Positioning Problem
2
2
Sticking
2
2
Leak/Splash
2
2
Loss of or Failure to Bond
2
2
Deformation Due to Compressive Stress
2
2
Device Sensing Problem
2
2
Inflation Problem
2
2
Gas/Air Leak
1
1
Infusion or Flow Problem
1
1
Material Twisted/Bent
1
1
Contamination
1
1
Failure to Advance
1
1
Device Inoperable
1
1
Material Puncture/Hole
1
1
Inadequate Lighting
1
1
Material Split, Cut or Torn
1
1
Retraction Problem
1
1
Component Missing
1
1
Contamination /Decontamination Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Physical Resistance/Sticking
1
1
Material Deformation
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device-Device Incompatibility
1
1
Off-Label Use
1
1
Hole In Material
1
1
Positioning Failure
1
1
Device Issue
1
1
Mechanical Jam
1
1
Device Damaged by Another Device
1
1
Material Too Rigid or Stiff
1
1
Difficult to Insert
1
1
Loose or Intermittent Connection
1
1
Kinked
1
1
Device Markings/Labelling Problem
1
1
Nonstandard Device
1
1
Failure to Unfold or Unwrap
1
1
Overheating of Device
1
1
Separation Problem
1
1
Packaging Problem
1
1
Failure to Shut Off
1
1
Display or Visual Feedback Problem
1
1
Device Expiration Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
61
61
No Known Impact Or Consequence To Patient
40
40
No Clinical Signs, Symptoms or Conditions
40
40
Foreign Body In Patient
21
21
Cerebrospinal Fluid Leakage
21
21
No Code Available
19
19
Pneumothorax
13
13
Device Embedded In Tissue or Plaque
9
9
No Information
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Cardiac Arrest
5
5
Hemorrhage/Bleeding
5
5
Swelling
4
4
Insufficient Information
4
4
No Patient Involvement
3
3
Perforation of Vessels
3
3
Low Oxygen Saturation
3
3
Pain
3
3
Brain Injury
3
3
Low Blood Pressure/ Hypotension
3
3
Stroke/CVA
3
3
Hypoxia
3
3
Death
3
3
Pulmonary Emphysema
2
2
Aspiration/Inhalation
2
2
Unspecified Infection
2
2
Perforation
2
2
Tissue Damage
2
2
Visual Impairment
2
2
Loss of Vision
1
1
Mediastinal Shift
1
1
Skin Tears
1
1
Blood Loss
1
1
Convulsion/Seizure
1
1
Epistaxis
1
1
Laceration(s)
1
1
Myocardial Infarction
1
1
Internal Organ Perforation
1
1
Hypoventilation
1
1
Asthma
1
1
Bradycardia
1
1
Burn(s)
1
1
Erythema
1
1
Eye Injury
1
1
Hearing Impairment
1
1
Hearing Loss
1
1
Stenosis
1
1
Sinus Perforation
1
1
Discomfort
1
1
Overinflation of Lung
1
1
Coma
1
1
Loss of consciousness
1
1
Respiratory Tract Infection
1
1
Paralysis
1
1
Tinnitus
1
1
Pulmonary Dysfunction
1
1
Staphylococcus Aureus
1
1
Increased Sensitivity
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
II
Apr-03-2024
2
Karl Storz Endoscopy
II
Dec-18-2023
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