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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, surgical instrument, pneumatic powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGET
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2016 29 39
2017 45 45
2018 46 46
2019 15 15
2020 15 15
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Align 49 51
Break 44 52
Difficult to Open or Close 21 21
Burst Container or Vessel 14 14
Detachment of Device or Device Component 11 11
Mechanical Problem 10 10
Detachment Of Device Component 7 7
Material Split, Cut or Torn 6 6
Product Quality Problem 5 5
Entrapment of Device 3 3
Material Rupture 2 2
Mechanics Altered 2 2
Overheating of Device 2 2
Defective Device 2 2
Inflation Problem 2 2
Unintended Ejection 2 2
Melted 1 1
Material Puncture/Hole 1 1
Failure to Cut 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance 1 1
Material Twisted/Bent 1 1
Bent 1 1
Material Integrity Problem 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Peeled/Delaminated 1 1
Unintended Movement 1 1
Excessive Heating 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 74 76
No Consequences Or Impact To Patient 27 30
No Patient Involvement 18 18
No Clinical Signs, Symptoms or Conditions 9 9
No Information 8 13
Hearing Loss 5 5
No Code Available 4 4
Tissue Damage 3 3
Hearing Impairment 2 2
Injury 2 2
Blood Loss 1 1
Chest Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Deafness 1 1
Tinnitus 1 1
Patient Problem/Medical Problem 1 1
Failure of Implant 1 1
Hip Fracture 1 1
Full thickness (Third Degree) Burn 1 1
Chest Tightness/Pressure 1 1
Foreign Body In Patient 1 1
Unspecified Tissue Injury 1 1
Death 1 1
Burn(s) 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MicroAire Surgical Instruments, LLC II May-27-2016
2 The Anspach Effort, Inc. II May-04-2017
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