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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

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Align 48 50
Break 40 48
Difficult to Open or Close 20 20
Burst Container or Vessel 14 14
Mechanical Problem 10 10
Detachment of Device or Device Component 9 9
Detachment Of Device Component 7 7
Material Split, Cut or Torn 6 6
Product Quality Problem 5 5
Entrapment of Device 2 2
Mechanics Altered 2 2
Overheating of Device 2 2
Unintended Ejection 2 2
Inflation Problem 2 2
Defective Device 2 2
Bent 1 1
Physical Resistance 1 1
Failure to Cut 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Tip 1 1
Knife 1 1
Noise, Audible 1 1
Material Puncture/Hole 1 1
Melted 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Excessive Heating 1 1
Peeled/Delaminated 1 1
Material Rupture 1 1
Material Integrity Problem 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 Information 8 13
Hearing Loss 5 5
No Code Available 4 4
Tissue Damage 3 3
Injury 2 2
Hearing Impairment 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Burn(s) 1 1
Failure of Implant 1 1
Hip Fracture 1 1
Partial thickness (Second Degree) Burn 1 1
Chest Tightness/Pressure 1 1
Blood Loss 1 1
Chest Pain 1 1
Deafness 1 1
Death 1 1
Tinnitus 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Full thickness (Third Degree) Burn 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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