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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scissors, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNF
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2015 18 18
2016 10 10
2017 5 5
2018 9 9
2019 19 19
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 41 41
Tip 13 13
Difficult to Open or Close 8 8
Knife 7 7
Detachment of Device or Device Component 6 6
Detachment Of Device Component 5 5
Failure to Cut 3 3
Mechanical Problem 2 2
Device Operates Differently Than Expected 2 2
Insufficient Information 2 2
Mechanical Jam 2 2
Device Inoperable 2 2
Positioning Problem 2 2
Device Fell 2 2
Physical Resistance/Sticking 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Corroded 1 1
Entrapment of Device 1 1
Sticking 1 1
Noise, Audible 1 1
Material Protrusion/Extrusion 1 1
Particulates 1 1
Material Separation 1 1
Inadequate or Insufficient Training 1 1
Cutter/Blade 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 21 21
No Patient Involvement 7 7
Foreign Body In Patient 3 3
No Code Available 2 2
No Information 1 1
Eye Injury 1 1
Unspecified Infection 1 1
Vitrectomy 1 1
Abscess 1 1

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