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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
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
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
16
16
Material Separation
15
15
Incorrect Interpretation of Signal
15
15
Adverse Event Without Identified Device or Use Problem
13
13
Material Rupture
9
9
Detachment of Device or Device Component
6
6
Patient Device Interaction Problem
5
5
Insufficient Information
4
4
Fracture
4
4
Material Fragmentation
3
3
Use of Device Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Deformation Due to Compressive Stress
2
2
Mechanical Problem
2
2
Loss of or Failure to Bond
2
2
Flaked
2
2
Crack
2
2
Device Sensing Problem
2
2
Difficult to Advance
2
2
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Device Markings/Labelling Problem
1
1
Device-Device Incompatibility
1
1
Physical Resistance/Sticking
1
1
Separation Problem
1
1
Deflation Problem
1
1
Positioning Failure
1
1
Display or Visual Feedback Problem
1
1
Contamination
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
42
42
Foreign Body In Patient
19
19
No Consequences Or Impact To Patient
16
16
No Known Impact Or Consequence To Patient
9
9
Pneumothorax
6
6
No Code Available
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Insufficient Information
4
4
No Information
3
3
Perforation of Vessels
3
3
Brain Injury
3
3
Cardiac Arrest
3
3
Stroke/CVA
3
3
Cerebrospinal Fluid Leakage
3
3
Death
2
2
Low Blood Pressure/ Hypotension
2
2
Hypoxia
2
2
Myocardial Infarction
1
1
Internal Organ Perforation
1
1
Pain
1
1
Paralysis
1
1
Hypoventilation
1
1
Overinflation of Lung
1
1
Coma
1
1
Loss of consciousness
1
1
Low Oxygen Saturation
1
1
No Patient Involvement
1
1
Pulmonary Dysfunction
1
1
Tissue Damage
1
1
Aspiration/Inhalation
1
1
Asthma
1
1
Loss of Vision
1
1
Mediastinal Shift
1
1
Convulsion/Seizure
1
1
Epistaxis
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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