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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
2016 53 53
2017 21 21
2018 16 16
2019 23 23
2020 25 25
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 101 101
Material Fragmentation 9 9
Fitting Problem 9 9
Device-Device Incompatibility 7 7
Device Operates Differently Than Expected 7 7
Material Twisted/Bent 5 5
Detachment of Device or Device Component 4 4
Fracture 3 3
Mechanical Jam 2 2
Component Missing 2 2
Compatibility Problem 2 2
Material Deformation 2 2
Device Difficult to Maintain 2 2
Dull, Blunt 1 1
Device Markings/Labelling Problem 1 1
Material Integrity Problem 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Failure to Cut 1 1
Device Or Device Fragments Location Unknown 1 1
Crack 1 1
Mechanical Problem 1 1
Material Separation 1 1
Device Slipped 1 1
Naturally Worn 1 1
Insufficient Information 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 48 48
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 34 34
No Clinical Signs, Symptoms or Conditions 13 13
No Information 3 3
No Code Available 2 2
Injury 2 2
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II Feb-25-2016
2 The Anspach Effort, Inc. II Feb-03-2016
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