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TPLC
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show TPLC since
2009
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2024
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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
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