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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
2020 15 15
2021 9 9
2022 13 13
2023 6 6
2024 19 19
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 18 18
Break 16 16
Detachment of Device or Device Component 13 13
Failure to Align 12 12
Material Split, Cut or Torn 7 7
Mechanical Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Entrapment of Device 1 1
Unintended Movement 1 1
Defective Component 1 1
Mechanics Altered 1 1
Difficult or Delayed Positioning 1 1
Material Rupture 1 1
Product Quality Problem 1 1
Excessive Heating 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 7 7
Insufficient Information 5 5
No Patient Involvement 4 4
Unspecified Tissue Injury 3 3
Tissue Breakdown 3 3
Burn(s) 2 2
No Code Available 1 1
No Known Impact Or Consequence To Patient 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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