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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
Product CodeGET
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 15 15
2021 9 9
2022 13 13
2023 6 6
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 17 17
Detachment of Device or Device Component 15 15
Failure to Align 10 10
Material Split, Cut or Torn 9 9
Mechanical Problem 6 6
Difficult to Open or Close 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Excessive Heating 2 2
Overheating of Device 2 2
Burst Container or Vessel 2 2
Unintended Ejection 2 2
Material Rupture 2 2
Defective Component 1 1
Entrapment of Device 1 1
Product Quality Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Consequences Or Impact To Patient 11 11
No Patient Involvement 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 4 4
Unspecified Tissue Injury 3 3
Burn(s) 2 2
Death 1 1
Failure of Implant 1 1
Tinnitus 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Unintended Radiation Exposure 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Apr-14-2023
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