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
Fluid/Blood Leak	27	27
Dull, Blunt	19	19
Fitting Problem	9	9
Leak/Splash	7	7
Component Missing	2	2
Material Separation	2	2
Detachment of Device or Device Component	2	2
Break	1	1
Mechanical Problem	1	1
Device Markings/Labelling Problem	1	1
Material Puncture/Hole	1	1
Ejection Problem	1	1
Material Fragmentation	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
Structural Problem	1	1
Device Dislodged or Dislocated	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	62	62
No Consequences Or Impact To Patient	6	6
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Retinal Degeneration	1	1
Internal Organ Perforation	1	1
Uveitis	1	1