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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Material Separation 15 15
Incorrect Interpretation of Signal 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Material Rupture 9 9
Patient Device Interaction Problem 5 5
Insufficient Information 4 4
Detachment of Device or Device Component 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
Difficult to Advance 2 2
Device Sensing Problem 2 2
Device-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Device Markings/Labelling 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 40 40
Foreign Body In Patient 17 17
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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