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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microtome, cryostat
Product CodeIDP
Regulation Number 864.3010
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 5 5
2017 1 1
2019 6 6
2020 2 2
2021 5 5
2022 5 5
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 17 17
Adverse Event Without Identified Device or Use Problem 9 9
Improper or Incorrect Procedure or Method 3 3
Human-Device Interface Problem 3 3
Fire 2 2
Human Factors Issue 2 2
Defective Component 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Scratched Material 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 13 13
Injury 11 11
Tissue Damage 5 5
Burn(s) 5 5
Tissue Breakdown 2 2
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Jun-04-2019
2 Thermo Fisher Scientific II Mar-21-2011
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