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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 10
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 19
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXCELENT INC.
  SUBSTANTIALLY EQUIVALENT 1
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL, LLC
  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 2
SINUSYS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 53 53
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 70 70
Break 40 40
Material Rupture 22 22
Material Separation 21 21
Detachment of Device or Device Component 20 20
Imprecision 19 19
Incorrect Interpretation of Signal 14 14
Material Fragmentation 12 12
Detachment Of Device Component 9 9
Burst Container or Vessel 7 7
Insufficient Information 7 7
Fracture 6 6
Use of Device Problem 6 6
Material Frayed 6 6
Unsealed Device Packaging 6 6
Bent 5 5
Improper or Incorrect Procedure or Method 5 5
Patient Device Interaction Problem 5 5
Scratched Material 5 5
Device Operates Differently Than Expected 4 4
Component Falling 4 4
Inflation Problem 4 4
Crack 3 3
Deflation Problem 3 3
Material Integrity Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Deformation Due to Compressive Stress 2 2
Aborted Charge 2 2
Difficult to Advance 2 2
Device Sensing Problem 2 2
Positioning Problem 2 2
Loss of or Failure to Bond 2 2
Flaked 2 2
Fluid/Blood Leak 2 2
Mechanical Problem 2 2
Leak/Splash 2 2
Material Puncture/Hole 2 2
Sticking 2 2
Temperature Problem 2 2
Device Inoperable 1 1
Failure to Unfold or Unwrap 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Loose or Intermittent Connection 1 1
Hole In Material 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Contamination 1 1
Difficult to Insert 1 1
Kinked 1 1
Positioning Failure 1 1
Display or Visual Feedback Problem 1 1
Device Expiration Issue 1 1
Packaging Problem 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Device-Device Incompatibility 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Device Damaged by Another Device 1 1
Device Markings/Labelling Problem 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Inadequate Lighting 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Component Missing 1 1
Device Issue 1 1
Contamination /Decontamination Problem 1 1
Failure to Advance 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 75 75
No Known Impact Or Consequence To Patient 52 52
No Clinical Signs, Symptoms or Conditions 40 40
Cerebrospinal Fluid Leakage 25 25
Foreign Body In Patient 22 22
No Code Available 19 19
Pneumothorax 13 13
No Information 11 11
Device Embedded In Tissue or Plaque 9 9
Swelling 9 9
Hemorrhage/Bleeding 7 7
No Patient Involvement 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cardiac Arrest 5 5
Stroke/CVA 5 5
Death 5 5
Insufficient Information 4 4
Brain Injury 3 3
Perforation of Vessels 3 3
Low Oxygen Saturation 3 3
Low Blood Pressure/ Hypotension 3 3
Hypoxia 3 3
Pain 3 3
Perforation 2 2
Unspecified Infection 2 2
Tissue Damage 2 2
Hearing Impairment 2 2
Eye Injury 2 2
Bone Fracture(s) 2 2
Pulmonary Emphysema 2 2
Aspiration/Inhalation 2 2
Visual Impairment 2 2
Loss of Vision 1 1
Mediastinal Shift 1 1
Iatrogenic Source 1 1
Skin Tears 1 1
Blood 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
Fluid Discharge 1 1
Convulsion/Seizure 1 1
Epistaxis 1 1
Asthma 1 1
Bradycardia 1 1
Burn(s) 1 1
Erythema 1 1
Headache 1 1
Hearing Loss 1 1
Hematoma 1 1
Hypoventilation 1 1
Arteriosclerosis 1 1
Tinnitus 1 1
Pulmonary Dysfunction 1 1
Staphylococcus Aureus 1 1
Increased Sensitivity 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Internal Organ Perforation 1 1
Pneumonia 1 1
Paralysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus Acmi, Incorporated II May-31-2013
2 Karl Storz Endoscopy II Apr-03-2024
3 Karl Storz Endoscopy II Dec-18-2023
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