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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pliers, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeHTC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 21 21
2018 16 16
2019 23 23
2020 25 25
2021 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 74 74
Device-Device Incompatibility 7 7
Device Operates Differently Than Expected 6 6
Material Twisted/Bent 5 5
Material Fragmentation 5 5
Detachment of Device or Device Component 5 5
Fracture 3 3
Material Deformation 3 3
Material Integrity Problem 2 2
Mechanical Jam 2 2
Compatibility Problem 2 2
Mechanical Problem 2 2
Device Difficult to Maintain 2 2
Component Missing 1 1
Failure to Cut 1 1
Loose or Intermittent Connection 1 1
Crack 1 1
Entrapment of Device 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 33 33
No Patient Involvement 32 32
No Clinical Signs, Symptoms or Conditions 25 25
No Known Impact Or Consequence To Patient 16 16
No Code Available 1 1
Foreign Body In Patient 1 1

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