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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urethrotome
Product CodeEZO
Regulation Number 876.4770
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2017 1 1
2018 3 3
2020 1 1
2021 1 1
2022 2 2
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Fracture 4 4
Mechanical Problem 2 2
Material Separation 2 2
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 5 5
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Device Embedded In Tissue or Plaque 1 1
Vessel Or Plaque, Device Embedded In 1 1
Laceration(s) 1 1
Necrosis 1 1
Swelling 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus America Inc. II Aug-31-2011
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