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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
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Align 20 20
Difficult to Open or Close 18 18
Detachment of Device or Device Component 10 10
Break 9 9
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
Physical Resistance/Sticking 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
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
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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