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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, ent manual surgical
Product CodeLRC
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
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
Mechanical Problem 2 2
Crack 2 2
Difficult to Advance 2 2
Device Sensing Problem 2 2
Flaked 2 2
Deformation Due to Compressive Stress 2 2
Loss of or Failure to Bond 2 2
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Separation Problem 1 1
Off-Label Use 1 1
Physical Resistance/Sticking 1 1
Device Markings/Labelling Problem 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Contamination 1 1
Deflation Problem 1 1
Positioning Failure 1 1
Material Twisted/Bent 1 1
Retraction Problem 1 1
Display or Visual Feedback Problem 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
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