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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
2021 9 9
2022 13 13
2023 6 6
2024 19 19
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 17 17
Failure to Align 11 11
Detachment of Device or Device Component 9 9
Break 8 8
Material Split, Cut or Torn 7 7
Mechanical Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Overheating of Device 2 2
Entrapment of Device 1 1
Defective Component 1 1
Defective Device 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Insufficient Information 6 6
Burn(s) 3 3
Unspecified Tissue Injury 3 3
Tissue Breakdown 3 3
Unintended Radiation Exposure 1 1

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