• 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 15 15
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 32 32
Crack 13 13
Break 9 9
Peeled/Delaminated 6 6
Improper or Incorrect Procedure or Method 6 6
Mechanical Problem 3 3
Fracture 3 3
Material Split, Cut or Torn 2 2
Device Markings/Labelling Problem 2 2
Failure to Power Up 2 2
Device Dislodged or Dislocated 2 2
Melted 2 2
Unexpected Shutdown 1 1
Device Tipped Over 1 1
Unintended Movement 1 1
Defective Device 1 1
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Electrical /Electronic Property Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
No Consequences Or Impact To Patient 8 8
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 7 7
Concussion 1 1
Patient Problem/Medical Problem 1 1

-
-