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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
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 14 14
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Defective Component 2 2
Fire 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 9 9
Injury 6 6
Burn(s) 5 5
Tissue Breakdown 2 2
Insufficient Information 2 2
Tissue Damage 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Jun-04-2019
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