• 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 lamp, surgical
Product CodeFTD
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 80 80
2020 105 105
2021 65 65
2022 136 136
2023 260 260
2024 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 428 428
Peeled/Delaminated 139 139
Crack 91 91
Adverse Event Without Identified Device or Use Problem 64 64
Corroded 56 56
Fluid/Blood Leak 48 48
Fracture 31 31
Device Fell 25 25
Break 14 14
No Apparent Adverse Event 8 8
Disconnection 7 7
Leak/Splash 7 7
Material Split, Cut or Torn 7 7
Flaked 4 4
Temperature Problem 4 4
Device Operational Issue 4 4
Improper or Incorrect Procedure or Method 4 4
Loose or Intermittent Connection 3 3
Material Disintegration 3 3
Positioning Failure 3 3
Appropriate Term/Code Not Available 3 3
Unexpected Shutdown 3 3
Unintended Electrical Shock 2 2
Difficult or Delayed Positioning 2 2
Moisture Damage 2 2
Unintended Collision 2 2
Material Erosion 2 2
Grounding Malfunction 2 2
Structural Problem 2 2
Scratched Material 2 2
Difficult to Advance 2 2
Material Integrity Problem 1 1
Mechanics Altered 1 1
Output Problem 1 1
Power Problem 1 1
Insufficient Information 1 1
Sparking 1 1
Device-Device Incompatibility 1 1
Pitted 1 1
Unstable 1 1
Use of Device Problem 1 1
Overheating of Device 1 1
Misassembled 1 1
Contamination 1 1
Electrical /Electronic Property Problem 1 1
Excessive Heating 1 1
Misassembly During Maintenance/Repair 1 1
Device Handling Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 512 512
No Consequences Or Impact To Patient 102 102
Irritation 25 25
Pain 19 19
No Known Impact Or Consequence To Patient 10 10
No Code Available 7 7
Perforation 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Patient Involvement 4 4
Radiation Exposure, Unintended 4 4
Hemorrhage/Bleeding 4 4
Burn(s) 3 3
Numbness 3 3
Skin Tears 3 3
Insufficient Information 3 3
No Information 2 2
Post Operative Wound Infection 2 2
Cardiac Perforation 2 2
Brain Injury 2 2
Stroke/CVA 2 2
Abrasion 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Nerve Damage 1 1
Discomfort 1 1
Scar Tissue 1 1
Scarring 1 1
Perforation of Vessels 1 1
Great Vessel Perforation 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Usa Sales Inc II Jan-19-2024
2 Maquet Cardiovascular Us Sales, Llc II Jun-21-2019
-
-