TPLC - Total Product Life Cycle

show TPLC since

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	23	23
Incorrect Interpretation of Signal	19	19
Contamination of Device Ingredient or Reagent	17	17
Material Separation	15	15
Adverse Event Without Identified Device or Use Problem	13	13
Patient Device Interaction Problem	8	8
Material Rupture	6	6
Detachment of Device or Device Component	6	6
Device Sensing Problem	6	6
Fracture	4	4
Improper or Incorrect Procedure or Method	4	4
Insufficient Information	3	3
Material Fragmentation	3	3
Device Contaminated During Manufacture or Shipping	2	2
Mechanical Problem	2	2
Crack	2	2
Difficult to Advance	2	2
Use of Device Problem	2	2
Failure to Cut	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
Off-Label Use	1	1
Physical Resistance/Sticking	1	1
Unsealed Device Packaging	1	1
Positioning Failure	1	1
Material Twisted/Bent	1	1
Retraction Problem	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	80	80
Foreign Body In Patient	22	22
No Consequences Or Impact To Patient	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumothorax	5	5
Insufficient Information	5	5
No Known Impact Or Consequence To Patient	4	4
Cerebrospinal Fluid Leakage	4	4
Stroke/CVA	3	3
Brain Injury	3	3
Aspiration/Inhalation	3	3
Cardiac Arrest	3	3
Perforation of Vessels	3	3
Death	2	2
Laceration(s)	2	2
Hypoxia	2	2
Low Blood Pressure/ Hypotension	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
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