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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
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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