TPLC - Total Product Life Cycle

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Device	cannula, trocar, ophthalmic
Regulation Description	Manual ophthalmic surgical instrument.
Definition	The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.
Product Code	NGY
Regulation Number	886.4350
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Dull, Blunt	34	34
Fluid/Blood Leak	31	31
Fitting Problem	9	9
Leak/Splash	5	5
Component Missing	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Detachment of Device or Device Component	2	4
Break	1	1
Mechanical Problem	1	1
Crack	1	1
Material Puncture/Hole	1	1
Defective Component	1	1
Ejection Problem	1	1
Difficult to Insert	1	1
Use of Device Problem	1	1
Gas/Air Leak	1	1
Material Twisted/Bent	1	1
Insufficient Flow or Under Infusion	1	1
Misconnection	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	74	76
Insufficient Information	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Retinal Tear	2	2
No Consequences Or Impact To Patient	1	1
Intraocular Pressure Decreased	1	1
Internal Organ Perforation	1	1
Retinal Detachment	1	1
Retinal Degeneration	1	1