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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device elevator
Product CodeHTE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 13 13
2018 7 7
2019 11 11
2020 12 12
2021 3 3
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 35
Contamination /Decontamination Problem 6 6
Crack 4 4
Device Contamination with Chemical or Other Material 3 3
Material Discolored 2 2
Material Fragmentation 2 2
Device Operates Differently Than Expected 2 2
Detachment Of Device Component 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
No Patient Involvement 14 14
No Clinical Signs, Symptoms or Conditions 10 10
No Known Impact Or Consequence To Patient 7 7
No Code Available 2 2
Foreign Body In Patient 1 1
Injury 1 1
Sedation 1 1
Blood Loss 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Pain 1 1
Swelling 1 1
Great Vessel Perforation 1 1

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