TPLC - Total Product Life Cycle

• Device: scissors, ophthalmic
• Product Code: HNF
• Regulation Number: 886.4350
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	20	20
2015	18	18
2016	10	10
2017	5	5
2018	9	9
2019	19	19
2020	10	10
2021	18	18
2022	20	20
2023	57	57
2024	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	86	86
Adverse Event Without Identified Device or Use Problem	40	40
Difficult to Open or Close	29	29
Failure to Cut	14	14
Detachment of Device or Device Component	6	6
Detachment Of Device Component	5	5
Material Fragmentation	4	4
Defective Device	3	3
Dull, Blunt	3	3
Mechanical Jam	3	3
Physical Resistance/Sticking	2	2
Device Fell	2	2
Device Operates Differently Than Expected	2	2
Positioning Problem	2	2
Insufficient Information	2	2
Material Separation	2	2
Device Inoperable	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2
Particulates	1	1
Corroded	1	1
Crack	1	1
Degraded	1	1
Entrapment of Device	1	1
Fitting Problem	1	1
Sticking	1	1
Inadequate or Insufficient Training	1	1
Failure to Align	1	1
Noise, Audible	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Protrusion/Extrusion	1	1
Material Twisted/Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	56	56
No Known Impact Or Consequence To Patient	50	50
Retinal Detachment	28	28
Retinal Tear	25	25
No Consequences Or Impact To Patient	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Visual Impairment	13	13
No Patient Involvement	7	7
Vitreous Hemorrhage	6	6
Insufficient Information	6	6
Foreign Body In Patient	4	4
Hemorrhage/Bleeding	3	3
No Code Available	2	2
Inflammation	2	2
Unspecified Tissue Injury	1	1
No Information	1	1
Vitrectomy	1	1
Unspecified Infection	1	1
Abscess	1	1
Eye Injury	1	1
Tissue Damage	1	1