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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cystotome
Product CodeHNY
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2019 3 3
2022 4 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Material Twisted/Bent 2 2
Material Fragmentation 2 2
Dull, Blunt 2 2
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1
Defective Component 1 1
Break 1 1
Appropriate Term/Code Not Available 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 2 2
Foreign Body Sensation in Eye 1 1
Unspecified Infection 1 1
Injury 1 1
Capsular Bag Tear 1 1

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