TPLC - Total Product Life Cycle

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Device	instrument, ent manual surgical
Product Code	LRC
Regulation Number	874.4420
Device Class	1

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	71	71
Break	41	41
Detachment of Device or Device Component	24	24
Material Rupture	22	22
Material Separation	21	21
Imprecision	19	19
Incorrect Interpretation of Signal	16	16
Contamination of Device Ingredient or Reagent	15	15
Material Fragmentation	12	12
Detachment Of Device Component	9	9
Patient Device Interaction Problem	7	7
Burst Container or Vessel	7	7
Insufficient Information	7	7
Fracture	6	6
Improper or Incorrect Procedure or Method	6	6
Material Frayed	6	6
Unsealed Device Packaging	6	6
Use of Device Problem	6	6
Scratched Material	5	5
Bent	5	5
Device Operates Differently Than Expected	4	4
Inflation Problem	4	4
Component Falling	4	4
Deflation Problem	3	3
Material Integrity Problem	3	3
Crack	3	3
Tear, Rip or Hole in Device Packaging	3	3
Fluid/Blood Leak	2	2
Temperature Problem	2	2
Loss of or Failure to Bond	2	2
Sticking	2	2
Difficult to Advance	2	2
Material Puncture/Hole	2	2
Device Sensing Problem	2	2
Positioning Problem	2	2
Aborted Charge	2	2
Mechanical Problem	2	2
Flaked	2	2
Leak/Splash	2	2
Deformation Due to Compressive Stress	2	2
Packaging Problem	1	1
Material Deformation	1	1
Retraction Problem	1	1
Loose or Intermittent Connection	1	1
Device Issue	1	1
Failure to Unfold or Unwrap	1	1
Mechanical Jam	1	1
Display or Visual Feedback Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	75	75
No Clinical Signs, Symptoms or Conditions	61	61
No Known Impact Or Consequence To Patient	52	52
Cerebrospinal Fluid Leakage	26	26
Foreign Body In Patient	26	26
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	8	8
No Patient Involvement	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Stroke/CVA	5	5
Death	5	5
Insufficient Information	5	5
Cardiac Arrest	5	5
Hearing Impairment	3	3
Low Oxygen Saturation	3	3
Low Blood Pressure/ Hypotension	3	3
Brain Injury	3	3
Hypoxia	3	3
Perforation of Vessels	3	3
Pain	3	3
Tissue Damage	2	2
Eye Injury	2	2
Visual Impairment	2	2
Perforation	2	2
Bone Fracture(s)	2	2
Pulmonary Emphysema	2	2
Aspiration/Inhalation	2	2
Unspecified Infection	2	2
Epistaxis	1	1
Burn(s)	1	1
Paralysis	1	1
Iatrogenic Source	1	1
Erythema	1	1
Nerve Damage	1	1
Staphylococcus Aureus	1	1
Discomfort	1	1
Respiratory Tract Infection	1	1
Blood Loss	1	1
Asthma	1	1
Laceration(s)	1	1
Sinus Perforation	1	1
Overinflation of Lung	1	1
Coma	1	1
Bradycardia	1	1
Hematoma	1	1
Pneumonia	1	1