TPLC - Total Product Life Cycle

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Device	instrument, vitreous aspiration and cutting, ac-powered
Regulation Description	Vitreous aspiration and cutting instrument.
Product Code	HQE
Regulation Number	886.4150
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fitting Problem	159	159
Adverse Event Without Identified Device or Use Problem	135	135
Failure to Cut	43	43
Suction Failure	31	31
Difficult to Insert	16	16
Break	11	11
Fluid/Blood Leak	10	10
Suction Problem	10	10
Defective Component	9	9
Particulates	8	8
Detachment of Device or Device Component	6	6
Energy Output Problem	5	5
Gas/Air Leak	5	5
Complete Blockage	4	4
Contamination /Decontamination Problem	4	4
Material Twisted/Bent	4	4
Material Deformation	4	4
Physical Resistance/Sticking	3	3
Loose or Intermittent Connection	3	3
Display or Visual Feedback Problem	3	3
Connection Problem	3	3
Contamination	3	3
Ambient Noise Problem	3	3
Inability to Irrigate	2	2
Defective Device	2	2
Appropriate Term/Code Not Available	2	2
Failure to Advance	2	2
Failure to Fire	2	2
Temperature Problem	1	1
Output below Specifications	1	1
Radiofrequency Interference (RFI)	1	1
Mechanical Jam	1	1
Component Incompatible	1	1
Device Contamination with Chemical or Other Material	1	1
Retraction Problem	1	1
Device Handling Problem	1	1
Delivered as Unsterile Product	1	1
Insufficient Flow or Under Infusion	1	1
Decrease in Pressure	1	1
Decrease in Suction	1	1
Improper Flow or Infusion	1	1
Use of Device Problem	1	1
Material Fragmentation	1	1
Difficult to Remove	1	1
Smoking	1	1
Device Fell	1	1
Filling Problem	1	1
Device Damaged Prior to Use	1	1
Crack	1	1
Accessory Incompatible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	269	269
Eye Infections	44	44
Insufficient Information	38	38
Transmissible Spongiform Encephalopathy(TSE)	33	33
Endophthalmitis	26	26
Retinal Tear	23	23
No Consequences Or Impact To Patient	12	12
Laceration(s)	9	9
Phototoxicity	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Inflammation	5	5
Foreign Body In Patient	5	5
Loss of Vision	5	5
No Known Impact Or Consequence To Patient	4	4
Hemorrhage/Bleeding	4	4
Intraocular Pressure Increased	3	3
Retinal Detachment	3	3
Blurred Vision	3	3
No Code Available	2	2
Eye Burn	2	2
Capsular Bag Tear	2	2
Intraocular Pressure Decreased	2	2
Iritis	1	1
Hematoma	1	1
Retinal Degeneration	1	1
No Patient Involvement	1	1
Eye Injury	1	1
Eye Pain	1	1