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	33	33
Contamination of Device Ingredient or Reagent	20	20
Material Separation	19	19
Incorrect Interpretation of Signal	19	19
Adverse Event Without Identified Device or Use Problem	14	14
Detachment of Device or Device Component	13	13
Patient Device Interaction Problem	9	9
Material Rupture	6	6
Device Sensing Problem	6	6
Mechanical Problem	5	5
Material Fragmentation	4	4
Fracture	4	4
Improper or Incorrect Procedure or Method	4	4
Insufficient Information	3	3
Device Contaminated During Manufacture or Shipping	2	2
Crack	2	2
Difficult to Advance	2	2
Use of Device Problem	2	2
Failure to Cut	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
Off-Label Use	1	1
Physical Resistance/Sticking	1	1
Unsealed Device Packaging	1	1
Positioning Failure	1	1
Material Twisted/Bent	1	1
Material Deformation	1	1
Retraction 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	99	99
Foreign Body In Patient	29	29
No Consequences Or Impact To Patient	9	9
Insufficient Information	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumothorax	5	5
Aspiration/Inhalation	4	4
No Known Impact Or Consequence To Patient	4	4
Cerebrospinal Fluid Leakage	4	4
Stroke/CVA	3	3
Brain Injury	3	3
Cardiac Arrest	3	3
Perforation of Vessels	3	3
Low Blood Pressure/ Hypotension	3	3
Death	2	2
Laceration(s)	2	2
Hypoxia	2	2
Hearing Impairment	1	1
Hypoventilation	1	1
Pulmonary Dysfunction	1	1
Mediastinal Shift	1	1
No Code Available	1	1
No Information	1	1
Asthma	1	1
Epistaxis	1	1
Paralysis	1	1
Pain	1	1
Overinflation of Lung	1	1
Coma	1	1
Swelling/ Edema	1	1
Myocardial Infarction	1	1
Tissue Damage	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Loss of Vision	1	1
Loss of consciousness	1	1
Airway Obstruction	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1