TPLC - Total Product Life Cycle

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Device	vitrectomy, instrument cutter
Regulation Description	Vitreous aspiration and cutting instrument.
Product Code	MLZ
Regulation Number	886.4150
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	372	372
Suction Failure	79	79
Suction Problem	39	39
Break	13	13
Air/Gas in Device	11	11
Material Twisted/Bent	7	7
Decrease in Suction	5	5
Mechanical Problem	4	4
Complete Blockage	4	4
Contamination	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Dull, Blunt	4	4
Disconnection	3	3
Therapeutic or Diagnostic Output Failure	3	3
Output Problem	2	2
Defective Device	2	2
Material Separation	2	2
Detachment of Device or Device Component	2	2
Leak/Splash	1	1
Fitting Problem	1	1
Chemical Problem	1	1
Entrapment of Device	1	1
Crack	1	1
Device Markings/Labelling Problem	1	1
Defective Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Power Up	1	1
Device Difficult to Setup or Prepare	1	1
Gas/Air Leak	1	1
Infusion or Flow Problem	1	1
Mechanics Altered	1	1
Failure to Prime	1	1
Retraction Problem	1	1
Failure to Calibrate	1	1
Loose or Intermittent Connection	1	1
Device Displays Incorrect Message	1	1
No Device Output	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	415	415
No Consequences Or Impact To Patient	33	33
Insufficient Information	32	32
No Known Impact Or Consequence To Patient	10	10
Intraocular Pressure Increased	4	4
Capsular Bag Tear	4	4
Eye Injury	4	4
Vitreous Hemorrhage	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Foreign Body In Patient	2	2
Intraocular Pressure Decreased	2	2
No Code Available	1	1
Retinal Injury	1	1
Joint Contracture	1	1
Device Embedded In Tissue or Plaque	1	1