TPLC - Total Product Life Cycle

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Device	cannula, trocar, ophthalmic
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
Leak/Splash	43	43
Fluid/Blood Leak	43	43
Dull, Blunt	17	17
Fitting Problem	6	6
Detachment of Device or Device Component	4	4
Detachment Of Device Component	4	4
Break	3	3
Device Operates Differently Than Expected	3	3
Device Operational Issue	3	3
Device Dislodged or Dislocated	2	2
Device Markings/Labelling Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Component Missing	2	2
Physical Resistance/Sticking	2	2
Component Falling	2	2
Material Fragmentation	2	2
Insufficient Flow or Under Infusion	2	2
Material Separation	2	2
Device Slipped	2	2
Device Inoperable	1	1
Use of Device Problem	1	1
Air Leak	1	1
Unintended Ejection	1	1
Collapse	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Difficult to Remove	1	1
Ejection Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Gas/Air Leak	1	1
Device Damaged Prior to Use	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	52
No Known Impact Or Consequence To Patient	48	48
No Consequences Or Impact To Patient	35	35
No Information	3	3
Endophthalmitis	2	2
Eye Injury	1	1
Hemorrhage/Bleeding	1	1
Internal Organ Perforation	1	1
Uveitis	1	1
No Code Available	1	1
Insufficient Information	1	1
No Patient Involvement	1	1