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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 2
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTERSECT ENT
  SUBSTANTIALLY EQUIVALENT 1
INTUIT MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
M/S. MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 32 32
2018 42 42
2019 19 19
2020 20 20
2021 23 23
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Material Rupture 18 18
Break 17 17
Material Separation 13 13
Detachment of Device or Device Component 7 7
Incorrect Interpretation of Signal 6 6
Detachment Of Device Component 6 6
Material Fragmentation 6 6
Material Frayed 6 6
Fracture 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Tear, Rip or Hole in Device Packaging 3 3
Crack 3 3
Deflation Problem 3 3
Component Falling 2 2
Burst Container or Vessel 2 2
Flaked 2 2
Fluid Leak 2 2
Mechanical Problem 2 2
Material Integrity Problem 2 2
Scratched Material 2 2
Temperature Problem 2 2
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Gas Leak 1 1
Infusion or Flow Problem 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Failure to Advance 1 1
Contamination /Decontamination Problem 1 1
Failure to Unfold or Unwrap 1 1
Component Missing 1 1
Device Issue 1 1
Contamination 1 1
Positioning Failure 1 1
Device Expiration Issue 1 1
Hole In Material 1 1
Imprecision 1 1
Inflation Problem 1 1
Kinked 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 45 45
No Known Impact Or Consequence To Patient 21 21
Foreign Body In Patient 17 17
No Clinical Signs, Symptoms or Conditions 16 16
No Code Available 14 14
Cerebrospinal Fluid Leakage 10 10
Pneumothorax 9 9
No Information 6 6
No Patient Involvement 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 3 3
Low Blood Pressure/ Hypotension 3 3
Hypoxia 2 2
Cardiac Arrest 2 2
Perforation 2 2
Insufficient Information 2 2
Brain Injury 1 1
Overinflation of Lung 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Blood Loss 1 1
Bradycardia 1 1
Burn(s) 1 1
Swelling 1 1
Tinnitus 1 1
Tissue Damage 1 1
Mediastinal Shift 1 1
Unspecified Infection 1 1
Myocardial Infarction 1 1
Pulmonary Emphysema 1 1
Hearing Loss 1 1
Hemorrhage/Bleeding 1 1

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