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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 422 422
Peeled/Delaminated 134 134
Crack 90 90
Adverse Event Without Identified Device or Use Problem 64 64
Corroded 56 56
Fluid/Blood Leak 48 48
Fracture 31 31
Device Fell 22 22
Break 14 14
Disconnection 7 7
Leak/Splash 7 7
No Apparent Adverse Event 7 7
Material Split, Cut or Torn 6 6
Improper or Incorrect Procedure or Method 4 4
Device Operational Issue 4 4
Flaked 4 4
Temperature Problem 4 4
Loose or Intermittent Connection 3 3
Unexpected Shutdown 3 3
Positioning Failure 3 3
Material Disintegration 3 3
Appropriate Term/Code Not Available 3 3
Structural Problem 2 2
Difficult or Delayed Positioning 2 2
Unintended Electrical Shock 2 2
Unintended Collision 2 2
Moisture Damage 2 2
Grounding Malfunction 2 2
Difficult to Advance 2 2
Material Erosion 2 2
Scratched Material 2 2
Mechanics Altered 1 1
Sharp Edges 1 1
Misassembly During Maintenance/Repair 1 1
Insufficient Information 1 1
Output Problem 1 1
Overheating of Device 1 1
Device-Device Incompatibility 1 1
Excessive Heating 1 1
Device Handling Problem 1 1
Sparking 1 1
Pitted 1 1
Power Problem 1 1
Material Integrity Problem 1 1
Unstable 1 1
Contamination 1 1
Misassembled 1 1
Electrical /Electronic Property Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 500 500
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
Hemorrhage/Bleeding 4 4
No Patient Involvement 4 4
Radiation Exposure, Unintended 4 4
Burn(s) 3 3
Skin Tears 3 3
Numbness 3 3
Insufficient Information 3 3
No Information 2 2
Brain Injury 2 2
Stroke/CVA 2 2
Post Operative Wound Infection 2 2
Cardiac Perforation 2 2
Scar Tissue 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Perforation of Vessels 1 1
Abrasion 1 1
Great Vessel Perforation 1 1
Discomfort 1 1
Burn, Thermal 1 1
Scarring 1 1
Nerve Damage 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
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