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 light, surgical, floor standing
Product CodeFSS
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 13 13
2020 9 9
2021 5 5
2022 3 3
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 21 21
Crack 10 10
Break 8 8
Improper or Incorrect Procedure or Method 6 6
Mechanical Problem 3 3
Peeled/Delaminated 3 3
Failure to Power Up 2 2
Melted 2 2
Fracture 2 2
Material Split, Cut or Torn 2 2
Device Markings/Labelling Problem 2 2
Device Dislodged or Dislocated 2 2
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Unexpected Shutdown 1 1
Defective Device 1 1
Device Tipped Over 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 20 20
No Consequences Or Impact To Patient 8 8
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 7 7
Patient Problem/Medical Problem 1 1

-
-