Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Human Factors Issue 6 6
Improper or Incorrect Procedure or Method 6 6
Device Handling Problem 6 6
Human-Device Interface Problem 4 4
Insufficient Information 2 2
Device Stops Intermittently 1 1
Physical Resistance/Sticking 1 1
Program or Algorithm Execution Failure 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Flare or Flash 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
-
-