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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 10 10

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 13 13
Material Split, Cut or Torn 9 9
Difficult to Open or Close 7 7
Mechanical Problem 6 6
Adverse Event Without Identified Device or Use Problem 3 3
Burst Container or Vessel 2 2
Unintended Ejection 2 2
Material Rupture 2 2
Excessive Heating 2 2
Overheating of Device 2 2
Entrapment of Device 1 1
Unintended Movement 1 1
Defective Component 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
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
Patient Problem/Medical Problem 1 1
Death 1 1
Failure of Implant 1 1
No Code Available 1 1
No Information 1 1
Partial thickness (Second Degree) Burn 1 1
Tinnitus 1 1
Full thickness (Third Degree) Burn 1 1
Unintended Radiation Exposure 1 1

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