TPLC - Total Product Life Cycle

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Device	instrument, ent manual surgical
Regulation Description	Ear, nose, and throat manual surgical instrument.
Product Code	LRC
Regulation Number	874.4420
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	38	38
Contamination of Device Ingredient or Reagent	20	20
Incorrect Interpretation of Signal	19	19
Material Separation	15	15
Detachment of Device or Device Component	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Patient Device Interaction Problem	9	9
Device Sensing Problem	6	6
Mechanical Problem	4	4
Material Fragmentation	4	4
Improper or Incorrect Procedure or Method	4	4
Insufficient Information	3	3
Failure to Cut	3	3
Device Contaminated During Manufacture or Shipping	2	2
Difficult to Advance	2	2
Use of Device Problem	2	2
Material Rupture	2	2
Fracture	2	2
Corroded	2	2
Deformation Due to Compressive Stress	2	2
Loss of or Failure to Bond	2	2
Device-Device Incompatibility	1	1
Separation Problem	1	1
Entrapment of Device	1	1
Unsealed Device Packaging	1	1
Material Twisted/Bent	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	104	104
Foreign Body In Patient	26	26
Insufficient Information	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Aspiration/Inhalation	4	4
Stroke/CVA	3	3
Pneumothorax	3	3
Pain	3	3
Perforation of Vessels	3	3
Cerebrospinal Fluid Leakage	3	3
Brain Injury	2	2
Cardiac Arrest	2	2
Laceration(s)	2	2
Low Blood Pressure/ Hypotension	2	2
Hearing Impairment	1	1
Hypoventilation	1	1
Pulmonary Dysfunction	1	1
No Information	1	1
Asthma	1	1
Epistaxis	1	1
Paralysis	1	1
Overinflation of Lung	1	1
Coma	1	1
Swelling/ Edema	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Loss of Vision	1	1
Airway Obstruction	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1