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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microtome, rotary
Product CodeIDO
Regulation Number 864.3010
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 4 4
2016 5 5
2017 4 4
2018 2 2
2019 8 8
2020 3 3
2021 7 7
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 18 18
Adverse Event Without Identified Device or Use Problem 15 15
Improper or Incorrect Procedure or Method 6 6
Device Handling Problem 6 6
Human Factors Issue 6 6
Human-Device Interface Problem 4 4
Insufficient Information 2 2
Misassembly by Users 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Device Operates Differently Than Expected 1 1
Patient-Device Incompatibility 1 1
Program or Algorithm Execution Failure 1 1
Flare or Flash 1 1
Device Stops Intermittently 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 25 25
Laceration(s) 24 24
Skin Tears 5 5
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Richard-Allan Scientific Company II Oct-12-2011
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